Label: AFTER 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 September 21, 2020

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  • Active Ingredient

    Lidocaine Hydrochloride 2.50%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of pain due to minor burns, sunburn, minor cuts, screapes or minor skin irritations

  • Warnings

    For external use only.

  • When using this product

    • avoid contact with eyes
    • do not use in large quantities, particularly over raw surfaces or blistered areas
    • do not use longer than 1 week unless directed by a doctor
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or 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 right away.

    If in eyes, flush with water for 15 minutes and call a doctor.

  • Directions

    Clean affected area

    Adults and Children 2 years and older apply small amount to affected area not more than 3 times daily

    Children under 2 years consult a doctor.

  • Inactive Ingredients

    Aloe Vera gel, benzalkonium chloride, carbomer 980, glycerol USP, herbal fragrance, menthol, polysorbate 20, propylene glycol, purified water, and sodium hydroxide (50%)

  • After Burn

    Box

  • INGREDIENTS AND APPEARANCE
    AFTER BURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90107-5120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90107-5120-11 in 1 BOX09/01/2020
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:90107-5120-0118 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2020
    Labeler - Adventure Ready Brands (064437304)
    Registrant - Adventure Ready Brands (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adventure Ready Brands064437304manufacture(90107-5120)
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