DailyMed - 4154 FIRST AID KIT kit 4139 FIRST AID KIT kit 4313 FIRST AID KIT kit

NDC Code(s): 0498-0114-01, 0498-0501-00, 0498-3334-00, 0498-4139-01, view more
0498-4154-01, 0498-4313-01
Packager: Honeywell Safety Products USA, INC

Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 10, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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First Aid Burn Cream Active ingredient

Benzalkonium chloride o.13%

Lidocaine HCl 0.5%
First Aid Burn Cream Purpose

First aid antiseptic

External analgesic
First Aid Burn Cream Uses
- prevent skin infection
- for temporary relief of pain associated with minor burns
First Aid Burn Cream Warnings
For external use only
Do not use
- in or near the eyes
- if you are allergic to any of the ingredients
- in large areas of the body, particularly over raw surfaces or blistered areas
- for more than 10 days
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occurs again within a few days
First Aid Burn Cream Directions
- adults and children 2 years of age and older:
- clean the affected area
- apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
- may be covered with a sterile bandage
- children under 2 years of age: consult a doctor
First Aid Burn Cream Other information
- tamper evident sealed packets
- do not use if packet is opened or torn
First Aid Burn Cream Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water
First Aid Burn Cream Questions

1-800-430-5490
Aspirin Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Aspirin Purpose

Pain reliever/fever reducer
Aspirin Uses
temporarily reduces fever and relieves minor aches and pains associated with:
- a cold
- headache
- toothache
- muscular aches
- backache
- minor pain of arthritis
- premenstrual and menstrual periods
Aspirin Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are:
- age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- ringing in the ears or loss of hearing occurs
- any new symptoms appear
If pregnant or breast-feeding,

If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
- In case of overdose, get medical help or contact Poison Control Center right away.
Aspirin Directions
- drink a full glass of water with each dose
- adults and children 12 years of age and older: take 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
- children under 12 years of age: consult a doctor
Aspirin Other information
- store at room temperature 15° - 30°C (59° - 86°F)
- TAMPER EVIDIENT PACKETS
- DO NOT USE IF OPEN OR TORN
Aspirin Inactive ingredients

corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*

*may contain these ingredients
Aspirin Questions or Comments

1-800-430-5490
BZK Active ingredient

Benzalkonium chloride 0.13% w/v
BZK Purpose

First aid antiseptic
BZK Uses

Antiseptic cleansing of face, hands, and body without soap and water
BZK Warnings
For external use only
Do not use
- in the eyes or over large areas of the body
- on mucous membranes
- on irritated skin
- in case of deep puncture wounds, animal bites or serious burns, consult a doctor
- longer than 1 week unless directed by a doctor
Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if
- irritation, redness or other symptoms develop
- the condition persists or gets worse
BZK Directions
- tear open packet and use as a washcloth
BZK Other information
- store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
- do not reuse towelette
BZK Inactive ingredients

water
BZK Questions

1-800-430-5490
Ammonia Active ingredient

Ammonia 15%
Ammonia Purpose

Respiratory stimulant
Ammonia Uses
- to prevent or treat fainting
Ammonia Warnings
For external use only
Do not use
- if you have breathing problems such as asthma or emphysema
Stop use and ask a doctor if
- condition persists
Keep out of reach of children
- If swallowed get medical help or contact a Poison Control Center immidiately
Ammonia Directions
- hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve.
- hold near nostrils for inhalation of volatile vapo
Ammonia Other information
- store at room temperature away from light
Ammonioa Inactive ingredients

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water
Ammonia Questions or Comments?

1-800-430-5490
4139 SF00004159 kit contents

1 3/4X3 PLAS SING 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 INSTANT COLD PACK 4" X 6"

1 ANTIMCRBL ANTSPTC TWLETTS

1 ADHESIVE TAPE W/P 1/2"X 5 YD

1 FIRST AID GUIDE ASHI

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 FIRST AID CREAM 0.9 GRM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 # 25 EMPTY NO LOGO BLANK

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 TRI BNDG NON WOVEN 40"X40"X56"

5 GAUZE PADS 3"X3" 12PLY

5 GAUZE PADS 4"X4" 12PLY

6 ASPIRIN BULK 2/PK

3 AMMONIA INHALANT, BULK
4154 68P25BR Kit Contents

1 3/4X3 PLAS SING 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 INSTANT COLD PACK 4" X 6"

1 ANTIMCRBL ANTSPTC TWLETTS

1 ADHESIVE TAPE W/P 1/2"X 5 YD

1 FIRST AID GUIDE ASHI

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 FIRST AID CREAM 0.9 GRM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 KIT, PP 16 UNIT FA

1 TRI BNDG NON WOVEN 40"X40"X56"

5 GAUZE PADS 3"X3" 12PLY

5 GAUZE PADS 4"X4" 12PLY

6 ASPIRIN BULK 2/PK

3 AMMONIA INHALANT, BULK
4313 SF00004513 kit contents

1 3/4X3 PLAS SING 50/BOX

1 GAUZE BANDAGE, 4" X 6 YD

1 NSTANT COLD PACK 4" X 6"

1 ANTIMCRBL ANTSPTC TWLETTS

1 ADHESIVE TAPE W/P 1/2"X 5 YD

1 FIRST AID GUIDE ASHI

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 ABD COMBINE PAD 5" X 9"

1 FIRST AID CREAM 0.9 GRM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 # 25 EMPTY NO LOGO BLANK

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 TRI BNDG NON WOVEN 40"X40"X56"

5 GAUZE PADS 3"X3" 12PLY

5 GAUZE PADS 4"X4" 12PLY

6 ASPIRIN BULK 2/PK

3 AMMONIA INHALANT, BULK
First Aid Burn Cream Principal Display Panel
Aspirin Principal Display Panel
BZK Principal Display Panel
Ammonia Principal Display Panel
4139 Kit Label SF00004159
4154 Kit Label 68P25BR
4313 Kit Label SF00004513

INGREDIENTS AND APPEARANCE

4154 FIRST AID KIT
4154 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4154

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4154-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	20 PACKET	18 g
Part 2	1 PACKET	1.4 mL
Part 3	6 PACKET	12
Part 4	3 AMPULE	0.9 mL

Part 1 of 4

FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC:0498-0903
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/20/2017

Part 2 of 4

ANTISEPTIC TOWELETTE
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC:0498-0501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0501-00	1.4 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/18/2018

Part 3 of 4

ASPIRIN
aspirin tablet

Product Information
Item Code (Source)	NDC:0498-0114
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FR21
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/18/2018

Part 4 of 4

AMMONIA INHALENT
ammonia inhalent inhalant

Product Information
Item Code (Source)	NDC:0498-3334
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-3334-00	0.3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/18/2018

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

4139 FIRST AID KIT
4139 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4139

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4139-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	20 PACKET	18 g
Part 2	1 PACKET	1.4 mL
Part 3	6 PACKET	12
Part 4	3 AMPULE	0.9 mL

Part 1 of 4

FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC:0498-0903
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/20/2017

Part 2 of 4

ANTISEPTIC TOWELETTE
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC:0498-0501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0501-00	1.4 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/18/2018

Part 3 of 4

ASPIRIN
aspirin tablet

Product Information
Item Code (Source)	NDC:0498-0114
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FR21
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/18/2018

Part 4 of 4

AMMONIA INHALENT
ammonia inhalent inhalant

Product Information
Item Code (Source)	NDC:0498-3334
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-3334-00	0.3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/18/2018

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

4313 FIRST AID KIT
4313 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4313

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4313-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	20 PACKET	18 g
Part 2	1 PACKET	1.4 mL
Part 3	6 PACKET	12
Part 4	3 AMPULE	0.9 mL

Part 1 of 4

FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC:0498-0903
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/20/2017

Part 2 of 4

ANTISEPTIC TOWELETTE
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC:0498-0501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0501-00	1.4 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/18/2018

Part 3 of 4

ASPIRIN
aspirin tablet

Product Information
Item Code (Source)	NDC:0498-0114
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FR21
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/18/2018

Part 4 of 4

AMMONIA INHALENT
ammonia inhalent inhalant

Product Information
Item Code (Source)	NDC:0498-3334
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-3334-00	0.3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/18/2018

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

Labeler - Honeywell Safety Products USA, INC (079287321)

Name	Address	ID/FEI	Business Operations
Establishment
James Alexander		040756421	manufacture(0498-3334)

Name	Address	ID/FEI	Business Operations
Establishment
Honeywell Safety Products USA, INC		079287321	pack(0498-4154, 0498-4139, 0498-4313)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		085752004	manufacture(0498-0114)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(0498-0903)

Name	Address	ID/FEI	Business Operations
Establishment
Changzhou Maokang Medical		421317073	manufacture(0498-0501)

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Published Date (What is this?)	Version	Files
May 13, 2019	3 (current)	download
May 6, 2019	2	download

	RxCUI	RxNorm NAME	RxTTY
1	212033	aspirin 325 MG Oral Tablet	PSN
2	212033	aspirin 325 MG Oral Tablet	SCD
3	212033	ASA 325 MG Oral Tablet	SY
4	1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN
5	1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD
6	1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY
7	1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN
8	1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD
9	1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Patch	SY
10	1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY
11	1038558	benzalkonium chloride 0.13 % Topical Swab	SY
12	1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY
13	1299889	ammonia 15 % Nasal Inhalant	PSN
14	1299889	ammonia 150 MG/ML Nasal Inhalant	SCD
15	1299889	ammonia 0.045 GM per 0.3 ML Nasal Inhalant	SY
16	1299889	ammonia 0.3 ML Nasal Inhalant	SY
17	1299889	ammonia 15 % Nasal Inhalant	SY

Label: 4154 FIRST AID KIT kit
4139 FIRST AID KIT kit
4313 FIRST AID KIT kit

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	NDC
1	0498-0114-01
2	0498-0501-00
3	0498-3334-00
4	0498-4139-01
5	0498-4154-01
6	0498-4313-01

Label: 4154 FIRST AID KIT kit4139 FIRST AID KIT kit4313 FIRST AID KIT kit

View Package Photos

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Do not use

Keep out of reach of children

Stop use and ask a doctor if

Do not use

Stop use and ask a doctor if

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

4154 FIRST AID KIT kit4139 FIRST AID KIT kit4313 FIRST AID KIT kit

Number of versions: 2

4154 FIRST AID KIT kit4139 FIRST AID KIT kit4313 FIRST AID KIT kit

4154 FIRST AID KIT kit4139 FIRST AID KIT kit4313 FIRST AID KIT kit

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4154 FIRST AID KIT kit4139 FIRST AID KIT kit4313 FIRST AID KIT kit

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Label: 4154 FIRST AID KIT kit
4139 FIRST AID KIT kit
4313 FIRST AID KIT kit

4154 FIRST AID KIT kit
4139 FIRST AID KIT kit
4313 FIRST AID KIT kit

4154 FIRST AID KIT kit
4139 FIRST AID KIT kit
4313 FIRST AID KIT kit

4154 FIRST AID KIT kit
4139 FIRST AID KIT kit
4313 FIRST AID KIT kit

4154 FIRST AID KIT kit
4139 FIRST AID KIT kit
4313 FIRST AID KIT kit