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.

----------

PS-2309 First Aid Burn Cream

Active Ingredient

Lidocaine HCI 0.5%

Purpose

Topical Analgesic

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Topical Antiseptic

Use(s)

For the temporary relief of pain and itching associated with:

• Sunburn • Minor burns • Insect bites • 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 doctor 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, Gylcerine, 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-2309 MC MASTERPS-2309 First Aid Burn Cream

FIRST AID BURN CREAM 
first aid burn cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS50 mg  in 10000 mg
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 10000 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
CETETH-20 (UNII: I835H2IHHX)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58228-2309-12000 in 1 CARTON07/31/2023
1900 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2023
Labeler - ProStat First Aid LLC (061263699)
Registrant - Dynarex Corporation (008124539)

Revised: 7/2023
Document Id: 0037a1a4-d748-2567-e063-6394a90a721c
Set id: 0037a1a4-d747-2567-e063-6394a90a721c
Version: 1
Effective Time: 20230711
 
ProStat First Aid LLC