BURN EASE- burn ease gel 
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.

----------

3832 Burn Ease

Active Ingredient

Lidocaine Hydrochloride 2%

Purpose

Analgesic

Use(s)

• For the temporary relief of pain associated with • Minor burns • Sunburn

Warnings

For External Use Only

Do not use

• On wounds or damaged skin

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

When using this product

• Avoid contact with the eyes

• Do not bandage tightly

Stop use and ask a doctor if

• Condition worsens

• Symptoms persist for more than 7 days

• Symptoms 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 (1-800-222-1222) right away.

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

• Children under 2 years of age: Consult a doctor

Other Information

• Store at room temperature

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Proplyene glycol, Propylparaben, Purified water, Tea tree leaf oil, Triethanolamine

Questions?

1-888-900-2920 8AM-4PM PST

Label

PS-3832-BX-MASTERBurn Ease

BURN EASE 
burn ease gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-3832
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
IMIDUREA (UNII: M629807ATL)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TEA TREE OIL (UNII: VIF565UC2G)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58228-3832-2600 in 1 CASE04/10/2023
1NDC:58228-3832-16 in 1 BOX
13.5 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: f71eb4f5-2281-5867-e053-6394a90aac57
Set id: f71eb4f5-2280-5867-e053-6394a90aac57
Version: 1
Effective Time: 20230317
 
ProStat First Aid LLC