4243 First Aid Kit by Honeywell Safety Products USA, INC 4243 FIRST AID KIT kit

4243 First Aid Kit by

Drug Labeling and Warnings

4243 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]

Eyewash Active ingredient

Sterile Water 99%

Eyewash Purpose

Eyewash

Eyewash Uses

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

Eyewash 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.

Eyewash 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

Eyewash Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyewash 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 right away.

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 vapor

Ammonia Other information

• store at room temperature away from light

Ammonia Inactive ingredient

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

Ammonia 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

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 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 ingredient

water

BZK Questions

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

1st Aid Antiseptic Spray WS Active ingredients

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

1st Aid Antiseptic Spray WS Purpose

Topical antiseptic

Topical anesthetic

1st Aid Antiseptic Spray WS Uses

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

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

1st Aid Antiseptic Spray WS 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 temperature above 120 0 F

Do not use

• in the eyes or other mucous membranes
• in cases of serious burns
• in case of deep orpuncture wounds
• for a 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 occurs again within a few days
• redness, swelling, or irritation occurs

Keep out of reach of children

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

1st Aid Antiseptic Spray WS 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

1st Aid Antiseptic Spray WS Other information

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

1st Aid Antiseptic Spray WS Inactive ingredients

dipropylene glycol, isobutane, N-butane, propane

1st Aid Antiseptic Spray Questions

1-800-430-5490

4243 68420AG KIT CONTENTS

1 INSTANT COLD PACK 4" X 6"

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

1 ADH BDG, CLOTH, 1"X3", 16 PER

1 FIRST AID GUIDE ASHI

1 GAUZE CLEAN-WRAP BDGE N/S 2"

1 FIRST AID SPRAY AEROSOL 3 OZ

1 WATER JEL BURN JEL 3.5G PKT 6

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 SPLINTER OUT 10 PIECES/PK

1 BANDAGE COMP 3" W/TELFA PAD 2

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

4 BZK ANTISEPTIC WIPE, BULK

1 PR LRG NITRILE GLVES ZIP BAG

1 WATER-JEL BURN DRESSING 2 X 6

1 KIT STL 16 UN (HORIZONTAL)

1 TRI BNDG NON WOVEN 40"X40"X56"

10 NON ADHERENT PAD 2" X 3"

1 WOVEN KNUCKLE 8'S

1 FINGERTIP "T" 8/BX

2 AMMONIA INHALANT, BULK

Eyewash Principal Display Panel

Ammonia Principal Display Panel

BZK Principal Display Panel

Burn Jel Principal Display Panel

1st Aid Antiseptic Spray WS Principal Display Panel

4243 Kit Label 68420AG

INGREDIENTS AND APPEARANCE

4243 FIRST AID KIT 
4243 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4243

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4243-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	21 g
Part 2	1 BOTTLE	118 mL
Part 3	2 AMPULE	0.6 mL
Part 4	1 CAN	85 g
Part 5	4 PACKET	5.6 mL

Part 1 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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
TEA TREE OIL (UNII: VIF565UC2G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)

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 2 of 5

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 PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

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 3 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 4 of 5

FIRST AID ANTISEPTIC WATER SOLUBLE 
benzethonium chloride, benzocaine spray

Product Information
Item Code (Source)	NDC: 0498-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.2 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
BUTANE (UNII: 6LV4FOR43R)
PROPANE (UNII: T75W9911L6)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0031-40	85 g in 1 CAN; 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	09/19/2018

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		10/18/2018

Labeler - 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(0498-4243)

Establishment
Name	Address	ID/FEI	Business Operations
Dixon Investments		115315822	manufacture(0498-0031)

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

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(0498-0501)