4400 FIRST AID KIT kit 4264 FIRST AID KIT kit 4266 FIRST AID KIT kit 4265 FIRST AID KIT kit 4310 FIRST AID KIT kit
4310 First Aid Kit by
Drug Labeling and Warnings
4310 First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, INC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Eyesaline Active ingredient
- Eyesaline Purpose
- Eyesaline Uses
-
Eyesaline
Warnings
For external use only-
Obtain immediate medical treatment for all open wounds in or near eyes.
To avoid contamination, do not touch tip of container to any surface.
Do not reuse. Once opened, discard.
Do not use
- if solution changes color or becomes cloudy
- if you have open wounds in or near the eyes, get medical help right away.
- Eyesaline Directions
- Eyesaline Inactive ingredients
- Eyesaline Questions
- Alcohol Wipe Active ingredient
- Alcohol Wipe Purpose
- Alcohol Wipe Uses
- Alcohol Wipe Warnings
- Alcohol Wipe Directions
- Alcohol Wipe Other information
- Alcohol Wipe Inactive ingredient
- Alcohol Wipe Questions
- Aypanal Active ingredient
- Aypanal Purpose
- Aypanaly Uses
-
Aypanal
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- If a skin rash occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription).
- If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
-
Aypanal
Directions
do not take more than directed (see overdose warning)
adults and children 12 years of age or older
- take two tablets every 4-6 hours while symptoms last
- do not take more than 12 tablets in 24 hours
children 6 to under 12 years of age
- take 1 tablet every 4-6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
children under 6 years consult a doctor
- Aypanal Other information
- Aypanal Inactive ingredients
- Aypanal Questions
- Neomycin Active ingredient
- Neomycin Purpose
- Neomycin Uses
- Neomycin Warnings
- Neomycin Direction
- Neomycin Other information
- Neomycin Inactive ingredient
- Neomycin Questions?
- Antiseptic Spray Active ingredient
- Antiseptic Spray Purpose
- Antiseptic Spray Uses
- Antiseptic Spray Warnings
- Antiseptic Spray Directions
- Antiseptic Spray Other information
- Antiseptic Spray Inactive ingredients
- Antiseptic Spray Questions
- Burn Spray Active ingredient
- Burn Spray Purpose
- Burn Spray Uses
-
Burn Spray
Warnings
For external use only
Flammable
- keep away from fire or flame
- contents under pressure
- do not puncture or incinerate container
- do not expose to temperatures above 120 0 F
Do not use
- in or near the eyes or other mucous membranes
- in case of serious burns
- in case of deep or puncture wounds
- for prolonged period of time
- on large portion of the body
- Burn Spray Directions
- Burn Spray Other information
- Burn Spray Inactive ingredients
- Hans Sanitizer Active ingredient
- Hand Santizer Purpose
- Hand Sanitizer Uses
- Hand Sanitizer Warnings
- Hand Sanitizer Directions
- Hand Sanitizer Other information
- Hand Sanitizer Inactive ingredients
- Hand Sanitizer Questions or Comments?
-
4265
FAK150CAB-CLSB kit contents
1 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
3 NEOMYCIN ANTIBIOTIC 10 PER
2 EYE DRESS PKT W/4 ADH STRIPS
1 TOURNIQUET, 1 PER
1 WIRE SPLINT 1 PER
1 ADH BAND, EXTRA LARGE, 6 PER
1 ALCOHOL PREP PADS 10P
1 ADHESIVE TAPE W/P 1/2"X 5 YD
2 O/H PUMP ANTISEPTIC 2 OZ ID F
2 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
2 TAPE ADHESIVE 1"X 5 YD PLSTC
20 HAND SANITIZER 0.9G WJ BULK
6 GAUZE CLEAN-WRAP BDGE N/S 2"
6 GAUZE CLEAN-WRAP BDGE N/S 4"
4 BLOODSTOPPER
2 NON-ADHERENT PADS 2"X3" 10'S
1 GZE PADS STERILE 2"X 2" 10'S
1 GZE PADS STERILE 3"X 3" 25'S
3 ELASTIC BANDAGE 3" X 4.5YD
1 CPR FILTERSHIELD 77-100
1 AYPANAL NON-ASP IND 2/ENV 100
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
8 PR LRG NITRILE GLVES ZIP BAG
2 WATER-JEL BURN DRESSING 4 X 4
1 KIT STL LARGE FA CABINET
1 LBL CONTENTS ANSI 2015 CL B
1 LBL CAB CVR ANSI 2015 CL B
2 TRI BNDG NON WOVEN 40"X40"X56"
3 COLD PACK UNIT 4"X6" BULK
-
4266
FAK200CAB-CLSB kit contents
1 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
3 NEOMYCIN ANTIBIOTIC 10 PER
3 EYE DRESS PKT W/4 ADH STRIPS
1 TOURNIQUET, 1 PER
1 WIRE SPLINT 1 PER
1 ADH BAND, EXTRA LARGE, 6 PER
2 ALCOHOL PREP PADS 10P
2 ADHESIVE TAPE W/P 1/2"X 5 YD
2 O/H PUMP ANTISEPTIC 2 OZ ID F
2 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
2 TAPE ADHESIVE 1"X 5 YD PLSTC
30 HAND SANITIZER 0.9G WJ BULK
8 GAUZE CLEAN-WRAP BDGE N/S 2"
8 GAUZE CLEAN-WRAP BDGE N/S 4"
4 BLOODSTOPPER
2 NON-ADHERENT PADS 2"X3" 10'S
2 GZE PADS STERILE 2"X 2" 10'S
2 GZE PADS STERILE 3"X 3" 25'S
4 ELASTIC BANDAGE 3" X 4.5YD
1 CPR FILTERSHIELD 77-100
2 AYPANAL NON-ASP IND 2/ENV 100
2 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
8 PR LRG NITRILE GLVES ZIP BAG
3 WATER-JEL BURN DRESSING 4 X 4
1 KIT STL DELUXE FA CABINET
1 POCKET FA CABINET LARGE
1 SHELF LG FA CABINET
1 LBL CONTENTS ANSI 2015 CL B
1 LBL CAB CVR ANSI 2015 CL B
8 CORNER STYROFOAM 3X3X3
3 TRI BNDG NON WOVEN 40"X40"X56"
4 COLD PACK UNIT 4"X6" BULK
-
4310
SF00004442 Kit Contents
1 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
3 NEOMYCIN ANTIBIOTIC 10 PER
2 EYE DRESS PKT W/4 ADH STRIPS
1 TOURNIQUET, 1 PER
1 WIRE SPLINT 1 PER
1 ADH BAND, EXTRA LARGE, 6 PER
1 ALCOHOL PREP PADS 10P
1 O/H PUMP ANTISEPTIC 2 OZ ID F
1 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
2 TAPE ADHESIVE 1"X 5 YD PLSTC
10 HAND SANITIZER 0.9G WJ BULK
4 GAUZE CLEAN-WRAP BDGE N/S 2"
4 GAUZE CLEAN-WRAP BDGE N/S 4"
4 BLOODSTOPPER
1 NON-ADHERENT PADS 2"X3" 10'S
1 GZE PADS STERILE 2"X 2" 10'S
1 GZE PADS STERILE 3"X 3" 25'S
1 ELASTIC BANDAGE 3" X 4.5YD
1 CPR FILTERSHIELD 77-100
1 AYPANAL NON-ASP IND 2/ENV 100
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
8 PR LRG NITRILE GLVES
2 WATER-JEL BURN DRESSING 4 X 4
1 KIT ST MED FA CABINET-SP SHELF
2 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
-
4400
FAKREF100-B Kit Contents
1 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
1 HAND SANITIZER 10/PER
1 NEOMYCIN OINT 0.9 GM , UNTZD 25/BX
2 EYE DRESS PKT W/4 ADH STRIPS
1 TOURNIQUET
1 WIRE SPLINT 1 PER
1 ADH BAND, EXTRA LARGE, 6 PER
1 ALCOHOL PREP PADS 10P
1 O/H PUMP ANTISEPTIC 2 OZ ID F
1 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
2 TAPE ADHESIVE 1"X 5 YD PLSTC
4 GAUZE CLEAN-WRAP BDGE N/S 2"
4 GAUZE CLEAN-WRAP BDGE N/S 4"
4 BLOODSTOPPER
1 NON-ADHERENT PADS 2"X3" 10'S
1 GZE PADS STERILE 2"X 2" 10'S
1 GZE PADS STERILE 3"X 3" 25'S
1 ELASTIC BANDAGE 3" X 4.5YD
1 CPR FILTERSHIELD 77-100
1 AYPANAL NON-ASP IND 2/ENV 100
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
LBL STOCK 6-3/8"X4"
1 LBL STOCK 3"x1-7/8"
2 2 PR LRG NITRILE GLVES ZIP BAG
2 BURN-STOP BURN DRESSING 4 X 4
2 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
- Eyesaline Principal Display Panel
- Alcohol Wipe Principal Display Panel
- Aypanal Principal Display Panel
- Neomycin Principal Display Panel
- Antiseptic Spray Principal Display Panel
- Burn Spray Principal Display Panel
- Hand sanitizer Principal Display Panel
- 4264 Kit Label FAK100CAB-CLSB
-
4264 Kit Contnets
FAK100CAB-CLSB
1 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
3 NEOMYCIN ANTIBIOTIC 10 PER
2 EYE DRESS PKT W/4 ADH STRIPS
1 TOURNIQUET, 1 PER
1 WIRE SPLINT 1 PER
1 ADH BAND, EXTRA LARGE, 6 PER
1 ALCOHOL PREP PADS 10P
1 O/H PUMP ANTISEPTIC 2 OZ ID F
1 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
2 TAPE ADHESIVE 1"X 5 YD PLSTC
10 HAND SANITIZER 0.9G WJ BULK
4 GAUZE CLEAN-WRAP BDGE N/S 2"
4 GAUZE CLEAN-WRAP BDGE N/S 4"
4 BLOODSTOPPER
1 NON-ADHERENT PADS 2"X3" 10'S
1 GZE PADS STERILE 2"X 2" 10'S
1 GZE PADS STERILE 3"X 3" 25'S
1 ELASTIC BANDAGE 3" X 4.5YD
1 CPR FILTERSHIELD 77-100
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
8 PR LRG NITRILE GLVES ZIP BAG
2 WATER-JEL BURN DRESSING 4 X 4
1 KIT ST MED FA CABINET-SP SHELF
1 LBL CONTENTS ANSI 2015 CL B
1 LBL CAB CVR ANSI 2015 CL B
2 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
- 4265 Kit Label FAK150CAB-CLSB
- 4266 Kit Label FAK200CAB-CLSB
- 4310 Kit Label SF00004442
- 4400 Kit Label FAKREF100-B
-
INGREDIENTS AND APPEARANCE
4400 FIRST AID KIT
4400 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4400 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4400-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 10 POUCH 4 mL Part 3 50 PACKET 100 Part 4 1 BOTTLE, SPRAY 59 mL Part 5 1 BOTTLE, SPRAY 59 mL Part 6 25 PACKET 22.5 g Part 7 10 PACKAGE 9 mL Part 1 of 7 EYESALINE EMERGENCY EYEWASH
purified water liquidProduct Information Item Code (Source) NDC: 0498-0100 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018 Part 2 of 7 ALCOHOL WIPE
isopropyl alcohol swabProduct Information Item Code (Source) NDC: 0498-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2018 Part 3 of 7 AYPANAL NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC: 0498-2001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code circle;U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2012 Part 4 of 7 BURN RELIEF
lidocaine hydrochloride sprayProduct Information Item Code (Source) NDC: 0498-0221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 24.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) HYPROMELLOSES (UNII: 3NXW29V3WO) TEA TREE OIL (UNII: VIF565UC2G) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0221-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/18/2018 Part 5 of 7 ANTISEPTIC
benzalkonium chloride sprayProduct Information Item Code (Source) NDC: 0498-0402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) GLYCERIN (UNII: PDC6A3C0OX) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0402-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/18/2018 Part 6 of 7 NEOMYCIN
antibiotic ointmentProduct Information Item Code (Source) NDC: 0498-0730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/31/2010 Part 7 of 7 INSTANT HAND SANITIZER
alcohol liquidProduct Information Item Code (Source) NDC: 59898-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) WATER (UNII: 059QF0KO0R) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 59898-420-36 0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/15/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4264 FIRST AID KIT
4264 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4264 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4264-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 10 POUCH 4 mL Part 3 50 PACKET 100 Part 4 1 BOTTLE, SPRAY 59 mL Part 5 1 BOTTLE, SPRAY 59 mL Part 6 30 PACKET 27 g Part 7 10 PACKAGE 9 mL Part 1 of 7 EYESALINE EMERGENCY EYEWASH
purified water liquidProduct Information Item Code (Source) NDC: 0498-0100 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018 Part 2 of 7 ALCOHOL WIPE
isopropyl alcohol swabProduct Information Item Code (Source) NDC: 0498-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2018 Part 3 of 7 AYPANAL NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC: 0498-2001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code circle;U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2012 Part 4 of 7 BURN RELIEF
lidocaine hydrochloride sprayProduct Information Item Code (Source) NDC: 0498-0221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 24.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) HYPROMELLOSES (UNII: 3NXW29V3WO) TEA TREE OIL (UNII: VIF565UC2G) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0221-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/18/2018 Part 5 of 7 ANTISEPTIC
benzalkonium chloride sprayProduct Information Item Code (Source) NDC: 0498-0402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) GLYCERIN (UNII: PDC6A3C0OX) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0402-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/18/2018 Part 6 of 7 NEOMYCIN
antibiotic ointmentProduct Information Item Code (Source) NDC: 0498-0730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/31/2010 Part 7 of 7 INSTANT HAND SANITIZER
alcohol liquidProduct Information Item Code (Source) NDC: 59898-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) WATER (UNII: 059QF0KO0R) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 59898-420-36 0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/15/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4266 FIRST AID KIT
4266 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4266 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4266-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BOTTLE 236 mL Part 2 20 POUCH 8 mL Part 3 100 PACKET 200 Part 4 2 BOTTLE, SPRAY 108 mL Part 5 2 BOTTLE, SPRAY 108 mL Part 6 30 PACKET 27 g Part 7 30 PACKAGE 27 mL Part 1 of 7 EYESALINE EMERGENCY EYEWASH
purified water liquidProduct Information Item Code (Source) NDC: 0498-0100 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018 Part 2 of 7 ALCOHOL WIPE
isopropyl alcohol swabProduct Information Item Code (Source) NDC: 0498-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2018 Part 3 of 7 AYPANAL NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC: 0498-2001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code circle;U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2012 Part 4 of 7 BURN RELIEF
lidocaine hydrochloride sprayProduct Information Item Code (Source) NDC: 0498-0221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 24.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) HYPROMELLOSES (UNII: 3NXW29V3WO) TEA TREE OIL (UNII: VIF565UC2G) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0221-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/18/2018 Part 5 of 7 ANTISEPTIC
benzalkonium chloride sprayProduct Information Item Code (Source) NDC: 0498-0402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) GLYCERIN (UNII: PDC6A3C0OX) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0402-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/18/2018 Part 6 of 7 NEOMYCIN
antibiotic ointmentProduct Information Item Code (Source) NDC: 0498-0730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/31/2010 Part 7 of 7 INSTANT HAND SANITIZER
alcohol liquidProduct Information Item Code (Source) NDC: 59898-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) WATER (UNII: 059QF0KO0R) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 59898-420-36 0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/15/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4265 FIRST AID KIT
4265 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4265 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4265-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 10 POUCH 4 mL Part 3 50 PACKET 100 Part 4 2 BOTTLE, SPRAY 108 mL Part 5 2 BOTTLE, SPRAY 108 mL Part 6 30 PACKET 27 g Part 7 20 PACKAGE 18 mL Part 1 of 7 EYESALINE EMERGENCY EYEWASH
purified water liquidProduct Information Item Code (Source) NDC: 0498-0100 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018 Part 2 of 7 ALCOHOL WIPE
isopropyl alcohol swabProduct Information Item Code (Source) NDC: 0498-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2018 Part 3 of 7 AYPANAL NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC: 0498-2001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code circle;U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2012 Part 4 of 7 BURN RELIEF
lidocaine hydrochloride sprayProduct Information Item Code (Source) NDC: 0498-0221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 24.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) HYPROMELLOSES (UNII: 3NXW29V3WO) TEA TREE OIL (UNII: VIF565UC2G) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0221-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/18/2018 Part 5 of 7 ANTISEPTIC
benzalkonium chloride sprayProduct Information Item Code (Source) NDC: 0498-0402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) GLYCERIN (UNII: PDC6A3C0OX) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0402-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/18/2018 Part 6 of 7 NEOMYCIN
antibiotic ointmentProduct Information Item Code (Source) NDC: 0498-0730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/31/2010 Part 7 of 7 INSTANT HAND SANITIZER
alcohol liquidProduct Information Item Code (Source) NDC: 59898-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) WATER (UNII: 059QF0KO0R) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 59898-420-36 0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/15/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4310 FIRST AID KIT
4310 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4310 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4310-01 1 in 1 KIT; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 10 POUCH 4 mL Part 3 50 PACKET 100 Part 4 1 BOTTLE, SPRAY 59 mL Part 5 1 BOTTLE, SPRAY 59 mL Part 6 30 PACKET 27 g Part 7 10 PACKAGE 9 mL Part 1 of 7 EYESALINE EMERGENCY EYEWASH
purified water liquidProduct Information Item Code (Source) NDC: 0498-0100 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 98.6 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0100-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/18/2018 Part 2 of 7 ALCOHOL WIPE
isopropyl alcohol swabProduct Information Item Code (Source) NDC: 0498-0143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0143-04 0.4 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/18/2018 Part 3 of 7 AYPANAL NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC: 0498-2001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code circle;U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2012 Part 4 of 7 BURN RELIEF
lidocaine hydrochloride sprayProduct Information Item Code (Source) NDC: 0498-0221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 24.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) HYPROMELLOSES (UNII: 3NXW29V3WO) TEA TREE OIL (UNII: VIF565UC2G) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0221-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/18/2018 Part 5 of 7 ANTISEPTIC
benzalkonium chloride sprayProduct Information Item Code (Source) NDC: 0498-0402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTOXYNOL 9 (UNII: 7JPC6Y25QS) GLYCERIN (UNII: PDC6A3C0OX) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0402-59 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/18/2018 Part 6 of 7 NEOMYCIN
antibiotic ointmentProduct Information Item Code (Source) NDC: 0498-0730 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/31/2010 Part 7 of 7 INSTANT HAND SANITIZER
alcohol liquidProduct Information Item Code (Source) NDC: 59898-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) WATER (UNII: 059QF0KO0R) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 59898-420-36 0.9 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/15/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 Labeler - Honeywell Safety Products USA, INC (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4264, 0498-4265, 0498-4266, 0498-4310, 0498-4400) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 manufacture(0498-2001) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0498-0730, 0498-0402, 0498-0221, 59898-420) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc. 167518617 manufacture(0498-0100) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical 421317073 manufacture(0498-0143)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.