Label: FIRST AID ONLY BURN- lidocaine hydrochloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2024

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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 DrugM01701/02/2020
    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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