4203 FIRST AID KIT kit 4256 FIRST AID KIT kit

4256 First Aid Kit by

Drug Labeling and Warnings

4256 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

Sterile Water 99%

Eyesaline Purpose

Eyewash

Eyesaline Uses

• for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

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.

Stop use and ask a doctor if

• you experience eye pain
• changes in vision
• continued redness or irritation of the eye
• condition worsens or persists

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Eyesaline Directions

• remove contacts before using
• twist top to remove
• flush the affected area as needed
• control rate of flow by pressure on the bottle
• if necessary, continue flushing with emergency eyewash or shower

Eyesaline Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyesaline Questions

1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

Povidone Iodine Swab Active ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

Povidone Iodine Swab Purpose

First aid antiseptic

Povidone Iodine Swab Uses

• first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Povidone Iodine Swab Warnings

For external use only

Do not use

• over large areas of the body
• on individuals who are allergic or sensitive to iodine

Ask a doctor before use if you have

• deep or puncture wounds,
• animal bites
• serious burns

When using this product

• do not use longer than one wek unless directed by a doctor

Stop use and ask a doctor if

• conditions persists or gets worse
• irritation and redness develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Povidone Iodine Swab Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

• clean affected area
• apply to affected area 1 to 3 times daily
• may be covered with a sterile bandage
• discard swab after single use

Povidone Iodine Swab Other information

• store at room temperature away from light
• keep from freezing or excessive heat
• do not use if package is torn or open

Povidone Iodine Swab Inactive ingredients

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

Povidone Iodine Swab Questions and comments

1-800-430-5490

Alcohol Wipe Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe Purpose

First aid antiseptic

Alcohol Wipe Uses

• first aid to help prevent infection in minor cuts, scrapes, and burns

Alcohol Wipe Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burn

When using this product

• do not use longer than one week unless directed by a doctor

Stop use and consult a doctor

• if condition persists or gets worse

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Alcohol Wipe Directions

• clean the affected area
• apply wipe to affected area 1 to 3 times daily
• may be covered with a sterile bandage
• discard wipe after single use

Alcohol Wipe Other information

store at room temperature 15 0 to 25 0 C (59 0 to 77 0F)

Alcohol Wipe Inactive ingredient

water

Alcohol Wipe Questions

1-800-430-5490

Aypanal Active ingredient

Acetaminophen 325 mg

Aypanal Purpose

Pain reliever/ fever reducer

Aypanaly Uses

• temporarily relieves minor aches and pains due to the common cold and headache - temporarily reduces fever

Keep out of reach of children.

Keep out of reach of children.

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.

Ask a doctor before use if you have

• liver disease

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning

• In case of accidental overdose, get medical help or contact a Poison Control Center right away.
• Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

• store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
• TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Aypanal Inactive ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Aypanal Questions

1-800-430-5490

Neomycin Active ingredient

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Neomycin Purpose

First aid antibiotic

Neomycin Uses

• first aid to help prevent infection in - minor cuts - scrapes - burns

Do not use

• in the eyes
• over large areas of the body

Neomycin Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• a rash or other allergic reaction develops
• you need to use longer than 1 week

Stop use and ask a doctor if

• the condition persists or gets worse
• a rash or other allergic reaction develops
• you need to use longer than 1 week

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away

Neomycin Direction

• clean the affected area
• apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
• may be covered with a sterile bandage

Neomycin Other information

store at 15 0 to 25 0 C (59 0 to 77 0 F)

Neomycin Inactive ingredient

petrolatum

Neomycin Questions?

1-800-430-5490

Antiseptic Spray Active ingredient

Benzalkonium chloride 0.13%

Antiseptic Spray Purpose

First aid antiseptic

Antiseptic Spray Uses

• first aid to help prevent infection in minor cuts, scrapes and burns

Antiseptic Spray Warnings

For external use only

Do not use

• in or near the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

• the condition persists or gets worse

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away

Antiseptic Spray Directions

• clean the affected area
• spray a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first

Antiseptic Spray Other information

• shake well
• store at room temperature 15 0-30 0 C (59 0 -86 0 F)

Antiseptic Spray Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

Antiseptic Spray Questions

1-800-430-5490

Burn Spray Active ingredient

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray Purpose

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray Uses

for the temporary relief of pain and itching and helps protect against infection in:

• minor cuts and scrapes
• burns
• sunburn
• insect bites
• minor skin irritations

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

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• condition clears up and recurs within a few days
• redness, swelling, or irritation occurs

Keep out of the reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Burn Spray Directions

• clean the affected area
• shake can well before using
• hold 4 - 6 inches from surface and spray area until wet
• may be covered with a sterile bandage, if bandaged let dry first
• for adult institutional use only
• not intended for use on children

Burn Spray Other information

• avoid inhaling
• use only as directed
• intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal

Burn Spray Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

4256 Z019720-0009L Kit Contents

2 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

1 3/4 X 3 WOVEN 100/BOX

1 NEOMYCIN ANTIBIOTIC 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

2 ALCOHOL PREP PADS 10P

4 PVP IODINE WIPES 10 PER

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

4 GAUZE CLEAN-WRAP BDGE N/S 2"

4 GAUZE CLEAN-WRAP BDGE N/S 3"

1 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 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

5 PR LRG NITRILE GLVES ZIP BAG

1 KIT ST MED FA CABINET-SP SHELF

1 LBL CONTENTS ANSI Z308.1-2009 REV B

1 LBL CAB CVR FA LOGO NORTH ID B

1 TRI BNDG NON WOVEN 40"X40"X56"

2 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

4203 Kit Label 019720-0009L

4203 Kit Contnets 019720-0009L

1 1X3 PLASTIC 100/BOX
1 FINGERTIP "T" WOVEN 40/BOX
1 SWIFT KNUCKLE 40/BX
1 3/4 X 3 WOVEN 100/BOX
1 NEOMYCIN ANTIBIOTIC 10 PER
1 EYE DRESS PKT W/4 ADH STRIPS
2 ALCOHOL PREP PADS 10P
4 PVP IODINE WIPES 10 PER
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
4 GAUZE CLEAN-WRAP BDGE N/S 2"
4 GAUZE CLEAN-WRAP BDGE N/S 3"
1 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 5 PR LRG NITRILE GLVES ZIP BAG
1 KIT ST MED FA CABINET-SP SHELF
1 LBL CONTENTS ANSI Z308.1-2009 REV B
1 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK

4256 Kit Label Z019720-0009L

INGREDIENTS AND APPEARANCE

4203 FIRST AID KIT 
4203 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4203

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4203-01	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	20 POUCH	8 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	10 PACKET	9 g

Part 1 of 7

EYESALINE EMERGENCY EYEWASH 
purified water liquid

Product 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 swab

Product 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

PVP IODINE WIPE 
povidone-iodine 10% swab

Product 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 7

AYPANAL NON-ASPIRIN 
acetaminophen tablet

Product 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 7

BURN RELIEF 
lidocaine hydrochloride spray

Product 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 7

ANTISEPTIC 
benzalkonium chloride spray

Product 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 7

NEOMYCIN 
antibiotic ointment

Product 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/2018

4256 FIRST AID KIT 
4256 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4256

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4256-01	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	20 POUCH	8 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	10 PACKET	9 g

Part 1 of 7

EYESALINE EMERGENCY EYEWASH 
purified water liquid

Product 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 swab

Product 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

PVP IODINE WIPE 
povidone-iodine 10% swab

Product 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 7

AYPANAL NON-ASPIRIN 
acetaminophen tablet

Product 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 7

BURN RELIEF 
lidocaine hydrochloride spray

Product 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 7

ANTISEPTIC 
benzalkonium chloride spray

Product 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 7

NEOMYCIN 
antibiotic ointment

Product 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

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(0498-4203, 0498-4256)

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)