Label: FIRST AID ONLY BURN- lidocaine hydrochloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 30, 2019

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  • • 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.

  • SPL UNCLASSIFIED SECTION


    QUESTIONS 800-835-2263

  • PRINCIPAL DISPLAY PANEL

    Carton Image

  • INGREDIENTS AND APPEARANCE
    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)
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