FIRST AID ONLY BURN- lidocaine hydrochloride gel 
Acme United Corporation

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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First Aid Only Burn Gel

• ACTIVE INGREDIENT

Lidocaine Hydrochloride 2%

• PURPOSE

External Analgesic

USES

Temporarily relieves pain associated with minor burns

WARNINGS

For external use only.

Avoid contact with eyes

Do not use

▪ in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

▪condition worsens

▪symptoms persist for more than 7 days

▪symptoms clear up and occur again in a few days

Keep out of reach of children.

. If swallowed get medical help or contact Poison Control immediately

DIRECTIONS

Adults and children 2 years and over:

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

INACTIVE INGREDIENTS

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.


QUESTIONS 800-835-2263

Carton Image

FIRST AID ONLY BURN 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5010(NDC:50382-020)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
IMIDUREA (UNII: M629807ATL)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5010-016 in 1 CARTON01/02/2020
13.5 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-5010-0225 in 1 CARTON01/02/2020
23.5 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0924-5010-003.5 g in 1 PACKET; Type 0: Not a Combination Product01/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/02/2020
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-5010) , repack(0924-5010)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-5010) , repack(0924-5010)

Revised: 12/2019
Document Id: 9af39fcd-0a58-26d0-e053-2a95a90a99a0
Set id: 9af39fcd-0a57-26d0-e053-2a95a90a99a0
Version: 1
Effective Time: 20191230
 
Acme United Corporation