4129 First Aid Kit by Honeywell Safety Products USA, INC 4129 FIRST AID KIT kit

4129 First Aid Kit by

Drug Labeling and Warnings

4129 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]

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

Pyrocaine Active ingredient

Benzocaine 20%

Benzethonium chloride 0.2%

Pyrocaine Purpose

Topical anesthetic

Topical antiseptic

Pyrocaine Uses

For the temporary relief of pain and itching, and to help protect against skin infection in:

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

Do not use

• in or near the eyes or over large portions of the body
• in case of deep or puncture wounds or on:
• raw surfaces
• blistered areas
• animal bites
• serious burns

Keep out of reach of children

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

Pyrocaine Warnings

For external use only

Flammable

• keep away from fire or flame
• contents under pressure
• do not puncture, incinerate or expose container to temperatures above 120 o F

Stop use and ask a doctor if

• If condition persists or worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Pyrocaine Directions

• clean the affected area
• shake can well before using
• hold can 6 to 12 inches away from the affected area and spray liberally
• apply to affected area not more than 3 times daily
• for adult institutional use only
• not intended for use on children

Pyrocaine Other information

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

Pyrocaine Inactive ingredients

butane,dipropylene glycol, isobutane, propane

PVP Active ingredient

Povidone-iodine 10%

(equivalent to 1% titratable iodine)

PVP Purpose

First aid antiseptic

PVP Uses

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

PVP Warnings

For external use only.

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 or persists for more than 72 hours
• irritation and redness develops

Keep out of reach of children.

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

PVP Directions

• clean the affected area
• apply1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first
• discard wipe after single use

PVP Other information

• do not use on individuals who are allergic or sensitive to iodine
• store at controlled temperature 59-86ºF (15-30ºC)
• do not use if pouch is open or torn

PVP Inactive ingredients

nonoxynol 9, water

PVP 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 Relef 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

alcohol Active ingredient

Isopropyl alcohol 70%

Alcohol Purpose

First aid antiseptic

Alcohol Uses

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

Alcohol Warnings

For external use only

Flammable, keep away from fire and flame

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 1 week unless directed by a doctor

Stop use and consult a doctor if

• condition persists or gets worse

Keep out of the reach of children

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

Alcohol Directions

• clean the affected area
• may be covered with a sterile bandage
• apply wipe to affeted are 1 to 3 times daily
• discard wipe after single use

Alcohol Other information

• store at room temperature 15 0 to 25 0 C (59 0 to 77 0 F)
• do not use if packet is torn or opened

Alcohol Inactive ingredient

water

Alcojol Questions

1-800-430-5490

Hydrocortisone Active ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrocortisone Purpose

Anti-itch cream

Hydrocortisone Uses

• for the temporary relief of itching associated with minor skin irritations and rashes

Hydrocortisone Warnings

For external use only

Ask a doctor before use

• if you are using any other hydrocortisone product

When using the product

• avoid contact with eyes
• do not begin use of any other hydrocortisone product unless you have consulted a doctor
• do not use for the treatment of diaper rash

Stop use and ask a doctor if

• condition worsens
• condition persists 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.

Hydrocortisone Directions

• adults and children 2 years and older:
• clean the affected area
• apply to the area not more than 3 to 4 times daily
• children under 2 years of age: consult a doctor

Hydrocortisone Other information

• store at room temperature (do not freeze)

Hydrocortisone Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Hydrocortisone 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

4129 SF00004226 Kit Contents

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 TRIANGULAR BDG, NON-STERILE

1 INSTANT COLD PACK 4" X 6"

1 ALCOHOL PREP PADS 10P

1 HYDROCORTISON,1.O%,1/32 OZ,10P

1 RESPONSE KIT BLOODBORNE PATHOG

1 SCISSOR BDGE 4" RED PLS HDL

1 BANDAGE COMP 2" W/TELFA PAD 4

1 BANDAGE COMP 4" W/TELFA PAD 1

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 1" X 3" PLASTIC BANDS 16/BAG

1 KIT STL 24 UN WHITE 01

1 PVP IODINE SWABS 10

1 STING Relief SWAB 10

1 PYRO-CAINE AERO 2/BX

1 RED BIO BAGS 2/BX

1 FACE MASK/EYE SHIELD

1 LIQD TRTMNT SYS 1 EA

1 DISP. TOWEL/WIPES 2EA

1 IMPERVIOUS GOWN 1 EA

Ammonia Principal Display Panel

Pyrocaine Principal Display Panel

PVP Principal Display Panel

Sting Relief Principal Display Panel

Alcohol Principal Display Panel

Hydrocortisone Principal Display Panel

BZK Principal Display Panel

4129 Kit Label SF00004226

INGREDIENTS AND APPEARANCE

4129 FIRST AID KIT 
4129 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4129

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4129-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 PACKET	9 g
Part 2	10 AMPULE	3 mL
Part 3	2 CAN	28.4 g
Part 4	10 POUCH	4 mL
Part 5	10 POUCH	3 mL
Part 6	4 PACKET	5.6 mL
Part 7	10 POUCH	4 mL
Part 8	10 PACKET	9 g

Part 1 of 8

HYDROCORTISONE 
anti-itch cream

Product Information
Item Code (Source)	NDC: 0498-0801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)

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	part348	03/06/2013

Part 2 of 8

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 8

PYROCAINE BURN 
benzocaine, benzethonium chloride aerosol, spray

Product Information
Item Code (Source)	NDC: 0498-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
1,1,3-TRI(3-TERT-BUTYL-4-HYDROXY-6-METHYLPHENYL)BUTANE (UNII: BF6E9O0XJN)
ISOBUTANE (UNII: BXR49TP611)
1,1,3-TRIS(2-CHLOROETHOXY)PROPANE (UNII: 4FEX9N888E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0011-77	14.2 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	part348	01/01/2018

Part 4 of 8

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
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

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 5 of 8

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 6 of 8

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 7 of 8

ALCOHOL WIPE 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 0498-0143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0143-04	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	part333A	09/18/2018

Part 8 of 8

HYDROCORTISONE 
anti-itch cream ointment

Product Information
Item Code (Source)	NDC: 0498-0800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0800-34	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	part348	03/06/2013	10/15/2019

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(0498-4129)

Establishment
Name	Address	ID/FEI	Business Operations
Dixon Investments		115315822	manufacture(0498-0011)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0800, 0498-0801)

Establishment
Name	Address	ID/FEI	Business Operations
Chanzhou Maokang Medical		421317073	manufacture(0498-0143, 0498-0501)

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

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