4129 FIRST AID KIT- 4129 first aid kit 
Honeywell Safety Products USA, INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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4129 First Aid Kit (alcohol wipes, HC cr, BZK wipe, Pyrocaine Sp, PVP wipe, amm. Inh, Sting relief- SF00004226)

Ammonia
Active ingredient

Ammonia 15%

Ammonia
Purpose

Respiratory stimulant

Ammonia
Uses

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

Ammonia
Other information

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:

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

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

Pyrocaine
Other information

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

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

PVP
Other information

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

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

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

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

Alcohol
Other information

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

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

Hydrocortisone
Other information

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

BZK
Other information

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

Ammonia Inhalant

Pyrocaine
Principal Display Panel

Pyrocaine

PVP
Principal Display Panel

PVP Swabs

Sting Relief
Principal Display Panel

Sting Relief

Alcohol
Principal Display Panel

Alcohol Preps

Hydrocortisone
Principal Display Panel

Hydrocortisone Cream

BZK
Principal Display Panel

BZK wipe

4129 Kit Label
SF00004226

4129 label

4129 FIRST AID KIT 
4129 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4129
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4129-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 PACKET 9 g
Part 210 AMPULE 3 mL
Part 32 CAN 28.4 g
Part 410 POUCH 4 mL
Part 510 POUCH 3 mL
Part 64 PACKET 5.6 mL
Part 710 POUCH 4 mL
Part 810 PACKET 9 g
Part 1 of 8
HYDROCORTISONE 
anti-itch cream
Product Information
Item Code (Source)NDC:0498-0801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/06/2013
Part 2 of 8
AMMONIA INHALENT 
ammonia inhalent inhalant
Product Information
Item Code (Source)NDC:0498-3334
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 3 of 8
PYROCAINE BURN 
benzocaine, benzethonium chloride aerosol, spray
Product Information
Item Code (Source)NDC:0498-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0011-7714.2 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2018
Part 4 of 8
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0733-000.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2017
Part 5 of 8
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 8
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/21/2017
Part 7 of 8
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/18/2018
Part 8 of 8
HYDROCORTISONE 
anti-itch cream ointment
Product Information
Item Code (Source)NDC:0498-0800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0800-340.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/06/201310/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
Labeler - Honeywell Safety Products USA, INC (079287321)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander040756421manufacture(0498-3334)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, INC079287321pack(0498-4129)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments115315822manufacture(0498-0011)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0800, 0498-0801)
Establishment
NameAddressID/FEIBusiness Operations
Chanzhou Maokang Medical421317073manufacture(0498-0143, 0498-0501)
Establishment
NameAddressID/FEIBusiness Operations
Sion Medical Biotext532775194manufacture(0498-0121)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America Inc874965262manufacture(0498-0733)

Revised: 10/2019
Document Id: 950e1bac-dc99-acaf-e053-2a95a90a05b2
Set id: 889b42f3-47ba-1eb7-e053-2995a90a69db
Version: 2
Effective Time: 20191016
 
Honeywell Safety Products USA, INC