4378 First Aid Kit by Honeywell Safety Products USA, INC 4378 FIRST AID KIT kit

4378 First Aid Kit by

Drug Labeling and Warnings

4378 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]

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 (5 0 - 86 0 F)
• do not reuse towelette

BZK Inactiave ingredient

water

BzK Questions

1-800-430-5490

Aypanal Active ingredient (in each tablet)

Acetaminophen 500 mg

Aypanal Purpose

Pain reliever/fever reducer

Aypanal 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.
• 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 skin reaction 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 use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

If pregnant or breastfeeding

• ask a health professional before use.

Keep out of reach of children.

Keep out of reach of children.

Overdose warning: In case ofl overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Aypanal Directions

• do not take more than directed (see overdose warning)
• adults and children 12 years of age and over: Take 2 tablets with water every 6 hours while symptoms last.
• do not take any more than 8 tablets in 24 hours.
• children under 12: consult a doctor

Aypanal Other information

• store at room temperature 15 0 -30 0 C (59 0 -86 0 F)
• TAMPER EVIDENT- DO NOT USE IF OPEN OR TORN

Aypanal Inactive igredients

microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Aypanal Questions or Comments

1-800-430-5490

FABC Active ingredient

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

FABC Purpose

First Aid antiseptic

External analgesic

FABC Uses

• prevent skin infection
• for temporary relief of pain associated with minor burns

FABC Warnings

For external use only

Do not use

• in or near the eyes
• if you are allergic to any of the ingredients
• lin 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

Keep out of reach of children

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

FABC 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

FABC 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

FABC Questions

1-800-430-5490

Sting Relief Active ingredient (in eachwipe)

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief Purpose

Antiseptic

Topical pain relief

Sting Rellief 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

4378 Z631580000 KIT CONTENTS

1 INSTANT COLD PACK 4" X 6"

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

1 TWEEZER PLASTICS 4"

1 FIRST AID GUIDE ASHI

1 ABD COMBINE PAD 5" X 9"

1 CPR FILTERSHIELD 77-100

1 FIRST AID BURN CREAM 0.9 GRM PKT 20

1 SCISSOR BDGE 4" RED PLS HDL

1 FANNY PACK RED FAK LOGO EMPTY

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

6 BZK ANTISEPTIC WIPE, BULK

1 1 PR LRG NITRILE GLVES ZIP BAG

1 1" X 3" PLASTIC BANDS 16/BAG

5 SAFETEC STING RELIEF WIPES BULK

1 TRI BNDG NON WOVEN 40"X40"X56"

3 GAUZE PADS 3"X3" 12PLY

2 HEAVY FLEX LARGE PATCH 2" X 3"

2 AYPANAL EXTRA BULK 2/PK

BZK Principal Display Panel

Aypanal Principal Display Panel

FABC Principal Display Panel

Sting Relief Principal Display Panel

4378 Kit Label Z631580000

INGREDIENTS AND APPEARANCE

4378 FIRST AID KIT 
4378 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4378

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4378-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	5 POUCH	2 mL
Part 2	6 PACKET	8.4 mL
Part 3	2 PACKET	4
Part 4	20 PACKET	18 g

Part 1 of 4

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
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.5 mL  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		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 2 of 4

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 3 of 4

AYPANAL EX 
acetaminophen tablet

Product Information
Item Code (Source)	NDC: 0498-2110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-2110-01	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	01/02/2017

Part 4 of 4

FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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 not final	part333A	12/20/2017

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
Honeywell Safety Products USA, INC		079287321	pack(0498-4378)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(0498-2110)

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

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

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