4204 FIRST AID KIT kit 4210 FIRST AID KIT kit 4257 FIRST AID KIT kit
4257 First Aid Kit by
Drug Labeling and Warnings
4257 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
- Povidone Iodine Swab Active ingredient
- Povidone Iodine Swab Purpose
- Povidone Iodine Swab Uses
- Povidone Iodine Swab Warnings
- Povidone Iodine Swab Directions
- Povidone Iodine Swab Other information
- Povidone Iodine Swab Inactive ingredients
- Povidone Iodine Swab Questions and comments
- 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
- Cough Drop Active ingredient (in each drop)
- Cough Drop Purpose
- Cough Drop Uses
-
Cough Drop
Warnings
Sore throat warning: if sore throat is severe, lasts for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly
Ask a doctor before use if you have:
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
- Cough Drop Directions
- Cough Drop Other information
- Cough Drop Inactive ingredients
- Cough Drop Questions or Comments?
-
4210
019722-0011L Kit Contents
2 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
2 3/4 X 3 WOVEN 100/BOX
3 NEOMYCIN ANTIBIOTIC 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
3 ALCOHOL PREP PADS 10P
4 PVP IODINE WIPES 10 PER
2 ADHESIVE TAPE W/P 1/2"X 5 YD
1 TWEEZER PLASTICS 4"
1 ADH BAND PLSTC EX-LG 25 PER
1 O/H PUMP ANTISEPTIC 2 OZ ID F
1 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
1 TAPE ADHESIVE 1"X 5 YD PLSTC
10 GAUZE CLEAN-WRAP BDGE N/S 2"
10 GAUZE CLEAN-WRAP BDGE N/S 3"
1 BLOODSTOPPER
3 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 250
1 CHERRY COUGH DROPS 50
2 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
1 LABEL NORTH CONTENTS 8X8 ID B
5 PR LRG NITRILE GLVES ZIP BAG
1 KIT STL DELUXE FA CABINET
1 POCKET FA CABINET LARGE
1 SHELF LG FA CABINET
1 LBL CONTENTS ANSI Z308.1-2009 REV B
1 LBL CAB CVR FA LOGO NORTH ID B
8 CORNER STYROFOAM 3X3X3
2 TRI BNDG NON WOVEN 40"X40"X56"
4 COLD PACK UNIT 4"X6" BULK
-
4257
Z019721-0100L
2 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
1 3/4 X 3 WOVEN 100/BOX
2 NEOMYCIN ANTIBIOTIC 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
3 ALCOHOL PREP PADS 10P
4 PVP IODINE WIPES 10 PER
1 ADHESIVE TAPE W/P 1/2"X 5 YD
1 TWEEZER PLASTICS 4"
1 ADH BAND PLSTC EX-LG 25 PER
1 O/H PUMP ANTISEPTIC 2 OZ ID F
1 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
1 TAPE ADHESIVE 1"X 5 YD PLSTC
5 GAUZE CLEAN-WRAP BDGE N/S 2"
5 GAUZE CLEAN-WRAP BDGE N/S 3"
1 BLOODSTOPPER
3 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 CHERRY COUGH DROPS 50
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
5 PR LRG NITRILE GLVES ZIP BAG
1 KIT STL LARGE FA CABINET
1 LBL CONTENTS ANSI Z308.1-2009 REV B
1 LBL CAB CVR FA LOGO NORTH ID B
2 TRI BNDG NON WOVEN 40"X40"X56"
3 COLD PACK UNIT 4"X6" BULK
- Eyesaline Principal Display Panel
- Povidone Iodine Swab 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
- Cough Drop Principal Display Panel
- 4204 Kit Label 019721-0010L
-
4204 Kit Contnets
019721-0010L
2 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
1 3/4 X 3 WOVEN 100/BOX
2 NEOMYCIN ANTIBIOTIC 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
3 ALCOHOL PREP PADS 10P
4 PVP IODINE WIPES 10 PER
1 ADHESIVE TAPE W/P 1/2"X 5 YD
1 TWEEZER PLASTICS 4"
1 ADH BAND PLSTC EX-LG 25 PER
1 O/H PUMP ANTISEPTIC 2 OZ ID F
1 O/H PUMP BURN RELIEF 2 OZ ID G
1 FIRST AID GUIDE ASHI
1 TAPE ADHESIVE 1"X 5 YD PLSTC
5 GAUZE CLEAN-WRAP BDGE N/S 2"
5 GAUZE CLEAN-WRAP BDGE N/S 3"
1 BLOODSTOPPER
3 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 CHERRY COUGH DROPS 50
1 4OZ BFS EYEWASH TRILINGUAL BOTTLE
1 SCISSOR BDGE 4" RED PLS HDL
1 1 LBL STOCK 6-3/8"X4"
1 LBL STOCK 4"X2-7/8"
1 LABEL NORTH CONTENTS 8X8 ID B
5 PR LRG NITRILE GLVES ZIP BAG
KIT STL LARGE FA CABINET
1 LBL CONTENTS ANSI Z308.1-2009 REV B
1 LBL CAB CVR FA LOGO NORTH ID B
1 BAG ZIPPER POLY 6 X 6 2 MIL
2 TRI BNDG NON WOVEN 40"X40"X56"
3 COLD PACK UNIT 4"X6" BULK
- 4210 Kit Label 019722-0011L
- 4257 Kit Label Z019721-0010L
-
INGREDIENTS AND APPEARANCE
4204 FIRST AID KIT
4204 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4204 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4204-01 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 30 POUCH 12 mL Part 3 40 POUCH 12 mL Part 4 50 PACKET 100 Part 5 1 BOTTLE, SPRAY 59 mL Part 6 1 BOTTLE, SPRAY 59 mL Part 7 20 PACKET 18 g Part 8 50 POUCH 50 Part 1 of 8 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 8 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 8 PVP IODINE WIPE
povidone-iodine 10% swabProduct Information Item Code (Source) NDC: 0498-0121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0121-00 0.3 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 unapproved drug other 09/18/2018 Part 4 of 8 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 5 of 8 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 6 of 8 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 7 of 8 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 8 of 8 COUGH DROP
menthol lozengeProduct Information Item Code (Source) NDC: 0498-1120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7 mg Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) CORN SYRUP (UNII: 9G5L16BK6N) SUCROSE (UNII: C151H8M554) Product Characteristics Color red (red) Score no score Shape OVAL Size 22mm Flavor CHERRY (cherry) Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-1120-00 1 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 final part341 09/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4210 FIRST AID KIT
4210 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4210 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4210-01 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 30 POUCH 12 mL Part 3 40 POUCH 12 mL Part 4 125 PACKET 250 Part 5 1 BOTTLE, SPRAY 59 mL Part 6 1 BOTTLE, SPRAY 59 mL Part 7 30 PACKET 27 g Part 8 50 POUCH 50 Part 1 of 8 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 8 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 8 PVP IODINE WIPE
povidone-iodine 10% swabProduct Information Item Code (Source) NDC: 0498-0121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0121-00 0.3 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 unapproved drug other 09/18/2018 Part 4 of 8 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 5 of 8 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 6 of 8 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 7 of 8 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 8 of 8 COUGH DROP
menthol lozengeProduct Information Item Code (Source) NDC: 0498-1120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7 mg Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) CORN SYRUP (UNII: 9G5L16BK6N) SUCROSE (UNII: C151H8M554) Product Characteristics Color red (red) Score no score Shape OVAL Size 22mm Flavor CHERRY (cherry) Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-1120-00 1 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 final part341 09/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/18/2018 4257 FIRST AID KIT
4257 first aid kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0498-4257 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-4257-01 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 30 POUCH 12 mL Part 3 40 POUCH 12 mL Part 4 50 PACKET 100 Part 5 1 BOTTLE, SPRAY 59 mL Part 6 1 BOTTLE, SPRAY 59 mL Part 7 20 PACKET 18 g Part 8 50 POUCH 50 Part 1 of 8 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 8 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 8 PVP IODINE WIPE
povidone-iodine 10% swabProduct Information Item Code (Source) NDC: 0498-0121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-0121-00 0.3 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 unapproved drug other 09/18/2018 Part 4 of 8 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 5 of 8 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 6 of 8 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 7 of 8 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 8 of 8 COUGH DROP
menthol lozengeProduct Information Item Code (Source) NDC: 0498-1120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7 mg Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) CORN SYRUP (UNII: 9G5L16BK6N) SUCROSE (UNII: C151H8M554) Product Characteristics Color red (red) Score no score Shape OVAL Size 22mm Flavor CHERRY (cherry) Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0498-1120-00 1 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 final part341 09/18/2018 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 Bestco 002149136 manufacture(0498-1120) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, INC 079287321 pack(0498-4204, 0498-4210, 0498-4257) 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) 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) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0121)
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