4304 First Aid Kit by Honeywell Safety Products USA, INC 4304 FIRST AID KIT kit

4304 First Aid Kit by

Drug Labeling and Warnings

4304 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

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

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 ingredients

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 - 8 06 F)
• do not reuse towelette

BZK Inactive ingredient

water

BZK Questions

1-800-430-5490

Triple Active ingredient (each gram contains)

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

Aspirin Active ingredient

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

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
• 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 ...

Aspirin Questions or comments?

1-800-430-5490

4304 SF00004326 Kit Contents

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 1X3 WOVEN SING 50/BOX

1 SWIFT KNUCKLE 40/BX

1 AMMONIA INHALANTS 10 PER

1 INSTANT COLD PACK 4" X 6"

1 ELASTIC TAPE 1" X 5YD

1 O/H TAPE ADHESIVE TRI-CUT

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

4 GAUZE CLEAN-WRAP BDGE N/S 2"

1 BLOODSTOPPER

1 GZE PADS STERILE 4"X 4" 10'S

1 GZE PADS STERILE 2"X 2" 25'S

1 CO-FLEX BANDAGE 2"X 5YDS TAN

1 COTTON TIPS 100 PER VIAL

1 ANTISEPTIC WIPES BZK CHL 20'S

1 ASPIRIN IND PK 5 GR 2/ENV 250

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 F A KIT EMPTY BLANK 140

1 TONGUE BLADES SR WRAPPED 6'S

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

2 PR LRG NITRILE GLVES ZIP BAG

2 TRI BNDG NON WOVEN 40"X40"X56"

10 NON ADHERENT PAD 2" X 3"

1 RED BIO BAGS 2/BX

Eyesaline Principal Display Panel

Burn Spray Principal Display Panel

Ammonia Principal Display Panel

BZK Principal Display Panel

Triple Principal Display Panel

Aspirin Principal Display Panel

4304 Kit Label SF00004362

INGREDIENTS AND APPEARANCE

4304 FIRST AID KIT 
4304 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4304

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4304-01	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	1 BOTTLE, SPRAY	59 mL
Part 3	20 PACKET	10 g
Part 4	10 AMPULE	3 mL
Part 5	20 PACKET	28 mL
Part 6	125 PACKET	250

Part 1 of 6

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 6

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 3 of 6

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 4 of 6

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 5 of 6

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	12/21/2017

Part 6 of 6

ASPIRIN 
aspirin tablet

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

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0114-01	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	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
James Alexander		040756421	manufacture(0498-3334)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, INC		079287321	pack(0498-4304)

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

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0750, 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(0498-0501)