4234 FIRST AID KIT- 4234 first aid kit

4234 First Aid Kit by

Drug Labeling and Warnings

4234 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]

Active ingredient

Ammonia 15%

Purpose

Respiratory stimulant

Uses

to prevent or treat fainting

Warnings

For external use only

Do not use

• if you have 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 right away.

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 vapor

Other information

store at room temperature away from light

Inactive ingredients

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

Questions or Comments

1-800-430-5490

Burn Jel Active ingredient

Lidocaine HCl 2.0%

Burn Jel Purpose

External analgesic

Burn Jel Uses

• temporarily relieves pain due to minor burns

Burn Jel Warnings

For external use only

Do not use

• on large areas of the body, particularly over raw surfaces or blistered areas

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• the condition gets worse
• symptoms persist for more than 7 days
• condition clears up and recurs within a few days

Keep out of reach of children

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

Burn JEl Directions

• adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor
• you may report a serious reaction to this product to 800-430-5490

Burn Jel Other information

• store at room temperature - do not use if opened or torn

Burn Jel Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water

Burn Jel Questions

1-800-430-5490

Triple Active ingredient

Bacitracin zinc 400 units

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

Polymyxin B sulfate 5000 units

Triple Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple Uses

first aid to help prevent infection in:

• minor cuts
• scrapes
• burns

Triple Warnings

For external use only

Allergy alert: do not use if you are allergic to any of the ingredients

Do not use

• in the eyes
• over large areas of the body
• Ask a doctor before use if you have
• a deep or puncture wounds
• animal bites
• serious burns

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 the reach of children

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

Triple Directions

• 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

Triple Other information

• store at 15 0 to 25 0 C (59 0 to 77 0 F)
• tamper evident sealed packets
• do not use if packet is torn or opened

Triple Inactive ingredient

petrolatum

Triple Questions?

1-800-430-5490

BZK Wipe Active ingredient

Benzalkonium chloride 0.13% w/v

BZK Wipe Purpose

First aid antiseptic

BzK Wipe Uses

Antiseptic cleansing of face, hands, and body without soap and water

BZK Wipe 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

Stop use and ask a doctor if

• if irritation, redness or other symptoms develop
• 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.

BZK Wipe Directions

tear open packet and use as a washcloth

BZK Wipe Other information

• store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
• do not reuse towelette

BZK Wipe Other information

water

BZK Wipe Questions

1-800-430-5490

Hydrogen Peroxide Active ingredient

Hydrogen peroxide 3%

Hydrogen Peroxide Purpose

First aid antiseptic

Hydrogen peroxide Uses

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

Hydrogen peroxide Warnings

For external use only

Do not use

• in the eyes or apply over large areas of the body
• longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

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

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.

Hydrogen peroxide 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

Hydrogen peroxide Other information

• store at room temperature

Hydrogen peroxide Inactive ingredient

purified water

Hydrogen peroxide Questions or Comments?

1-800-430-5490

4234 68180SIGMA Kit Contents

1 WOVEN 7/8 X 3 50/BOX

1 FNGERTP LRG WOVEN 25/BOX

1 FNGERTP WOVEN REG 40/BOX

1 WOVEN 2" X 3" 25/BOX

1 SWIFT KNUCKLE 40/BX

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 BURN JEL 1/8 OZ, 6 PER

1 NITRILE GLOVES 2PR BBP

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

1 HYDROGEN PEROXIDE SPRAY PUMP

1 GAUZE BANDAGE 4"X2 YDS STRETCH GZ

1 FIRST AID GUIDE ASHI

2 BLOODSTOPPER

1 NON ADHERENT PADS 2"X3" 50'S

1 COTTON BALLS STERILE 130

1 ANTISEPTIC WIPES BZK CHL 20'S

1 TRIPLE BIOTIC .5 GRAM PKT 20

2 COLD PACK 5"X9" BOXED

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 180 EMPTY BLANK NO LOGO

1 BANDAGE COMP 3" W/TELFA PAD 2

LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 TRI BNDG NON WOVEN 40"X40"X56"

Principal Display Panel

Burn Jel Principal Display Panel

Triple Principal Display Panel

BZK Wipe Principal Display Panel

Hydrogen peroxide Principal Display Panel

4234 Kit Label 68180SIGMA

INGREDIENTS AND APPEARANCE

4234 FIRST AID KIT 
4234 first aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4234

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4234-01	1 in 1 KIT	09/13/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, SPRAY	59 mL
Part 2	10 AMPULE	3 mL
Part 3	6 PACKET	21 g
Part 4	20 PACKET	10 g
Part 5	20 PACKET	28 mL

Part 1 of 5

WATER JEL HYDROGEN PEROXIDE 
hydrogen peroxide spray

Product Information
Item Code (Source)	NDC: 59898-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	3 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-403-10	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	part333A	05/01/2013

Part 2 of 5

AMMONIA INHALENT 
ammonia inhalent inhalant

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-3334-00	0.3 mL in 1 AMPULE; 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 3 of 5

BURN JEL 
gel for burns gel

Product Information
Item Code (Source)	NDC: 0498-0203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0203-00	3.5 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 not final	part348	09/19/2018

Part 4 of 5

TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information
Item Code (Source)	NDC: 0498-0750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0750-36	0.5 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	09/19/2018

Part 5 of 5

ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0501-00	1.4 mL 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	part333E	12/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/13/2018

Labeler - Honeywell Safety Products USA, Inc. (079287321)

Registrant - Honeywell Safety Products USA, Inc. (079287321)

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

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	pack(0498-4234)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0203, 0498-0750, 59898-403)

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