FIRST AID BURN CREAM- first aid burn cream cream 
ProStat First Aid LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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2044 First Aid Burn Cream

Active Ingredient

Benzalkonium Chloride 0.13%

Active Ingredient

Lidocaine Hydrochloride 0.5%

Purpose

Benzalkonium Chloride Topical Antiseptic

Lidocaine Hydrochloride Topical Analgesic

Use(s)

• For the temporary relief of pain and itching associated with:

• Sunburn • Minor burns • Insect bites • Minor skin irritation • Cuts • Scrapes

Warnings

For External Use Only

Do not use

• In the eyes

• Over large areas of the body or on deep puncture wounds, animal bites, or serious burns

• In large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a dioctor if

• The condition gets worse

• Condition clears up and recurs within a few days

• Condition persists for more than 7 days

If pregnant or breast feeding

ask a health care professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 2 years and over:

• Clean the affected area

• Apply a small amount of this product on the area 3 to 4 times daily

• May be covered with a sterile bandage

Children under 2 years:

• Consult a doctor

Other Information

• Store in a cool, dry area 15º-25ºC (59º-77ºF)

• Tamper evident sealed packets

• Do not use any opened or torn packets

Inactive Ingredients

Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST.

Label

PS-2044-BX-MASTERFirst Aid Burn Cream

FIRST AID BURN CREAM 
first aid burn cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16)0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)  
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CETETH-20 (UNII: I835H2IHHX)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58228-2044-21800 in 1 CASE04/10/2023
1NDC:58228-2044-125 in 1 BOX
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 finalpart34804/10/2023
Labeler - ProStat First Aid LLC (061263699)

Revised: 3/2023
Document Id: f70a442e-7ba8-4860-e053-6394a90ac2bd
Set id: f70a442e-7ba7-4860-e053-6394a90ac2bd
Version: 1
Effective Time: 20230316
 
ProStat First Aid LLC