4364 First Aid Kit by Honeywell Safety Products USA, INC 4364 FIRST AID KIT kit

4364 First Aid Kit by

Drug Labeling and Warnings

4364 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]

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

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

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

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.

Keep out of reach of children.

Keep out of reach of children.

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

Triple Active ingredients (eeach 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

Sting Relief Active ingredient (in each wipe)

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief Purpose

Antiseptic

Topical pain relief

Sting Relief Uses

• prevent infection in minor scrapes, and temporary relief of itching of insect bites

Sting Relief Warnings

For external use only

Flammable, keep away from open fire or flame

Do not use

• over large areas of the body
• in eyes
• over raw or blistered areas

Stop use and ask a doctor

• if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Sting Relief Directions

• adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.
• children under 2 years of age: consult a doctor.

Sting Relief Inactive ingredients

benzalkonium chloride, menthol, and purified water

Sting Relief 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 ingredients

water

BZK Questions

1-800-430-5490

4364 SF00003201 Kit Contents

1 TRIPLE ANTIBIOTIC 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

2 TRIANGULAR BDG, NON-STERILE

1 WIRE SPLINT 1 PER

1 GAUZE PADS, 3" X 3", 4 PER

1 ADH TAPE, .5" X 2.5 YD, 2 PER

1 AYPANAL 26 PER

1 GAUZE BANDAGE, 2" X 6 YD,2 PER

1 INSTANT COLD PACK 4" X 6"

1 ADHESIVE BDG,PLSTIC,1"X3"16PER

1 FINGERTIP BANDAGE, 10 PER

1 BURN JEL 1/8 OZ, 6 PER

1 PVP IODINE WIPES 10 PER

1 STING RELIEF WIPES 10 PER BOX

1 ANTIMCRBL ANTSPTC TWLETTS

1 FIRST AID GUIDE ASHI

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

2 PR LRG NITRILE GLVES ZIP BAG

1 KIT STL 24 UN WHITE 01

Burn Jel Principal Display Panel

Povidone Iodine Swab Principal Display Panel

Aypanal Principal Display Panel

Triple Principal Display Panel

Sting Relief Principal Display Panel

BZK Principal Display Panel

4364 Kit Label SF00003201

INGREDIENTS AND APPEARANCE

4364 FIRST AID KIT 
4364 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4364

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4364-01	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 PACKET	1.4 mL
Part 2	10 POUCH	4 mL
Part 3	10 PACKET	9 g
Part 4	10 POUCH	3 mL
Part 5	6 PACKET	21 g
Part 6	26 PACKET	52

Part 1 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	12/22/2017

Part 2 of 6

STING RELIEF PAD 
ethyl alcohol, lidocaine swab

Product Information
Item Code (Source)	NDC: 0498-0733
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.5 mL  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0733-00	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	part348	12/23/2017

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
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [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: 0498-0750-35	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	09/19/2018

Part 4 of 6

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 5 of 6

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

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 6 of 6

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

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(0498-4364)

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(0498-0203, 0498-0750)

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

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical		532775194	manufacture(0498-0121)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America Inc		874965262	manufacture(0498-0733)