PS-3866 BURN EASE, 0.9G- ps-3866 burn ease, 0.9g 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.

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PS-3866 Burn Ease 0.9g

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, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

Questions?

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

Label

PS-3866 BX MASTERPS-3866 Burn Ease, 0.9g

PS-3866 BURN EASE, 0.9G 
ps-3866 burn ease, 0.9g gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-3866
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 HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
IMIDUREA (UNII: M629807ATL)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58228-3866-11000 in 1 CARTON07/31/2023
110 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 finalpart34807/31/2023
Labeler - ProStat First Aid LLC (061263699)
Registrant - Dynarex Corporation (008124539)

Revised: 7/2023
Document Id: 004d00a5-9d00-29ff-e063-6294a90aeb8c
Set id: 004d00a5-9cff-29ff-e063-6294a90aeb8c
Version: 1
Effective Time: 20230712
 
ProStat First Aid LLC