Label: NUMBING CREAM- lidocaine cream

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

Drug Label Information

Updated May 19, 2025

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  • ACTIVE INGREDIENT

    4% lidocaine

  • PURPOSE

    topical analgesic

  • INDICATIONS & USAGE

    For the temporary relief of pain and itching, associated with minor skin irritations, minor burns, sunburn, minor cuts, scrapes, insect bites.

  • WARNINGS

    For external use only

    Do not use this product if

    • Pregnant or breastfeeding, ask a health professional before use.
    • If there is any allergic reaction to this product.
    • In case of accidental overdose, get medical help, or contact the poison control center immediately.

    • Only take the recommended daily dosage unless otherwise instructed by a doctor.
    • Some individuals may experience allergic reactions to the ingredients contained in this product.

    Stop using and ask a doctor

    • If discomfort persists for 7 days.
    • The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.

    Keep out of reach of children Avoid contact with eyes.
    In case of accidental ingestion, seek medical attention immediately.

  • DOSAGE & ADMINISTRATION

    • For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
    • Apply up to 4 times a day.
    • For children under 12 years of age: Consult a doctor.
  • OTHER SAFETY INFORMATION

    Store at 59°-86°F (15°-30°C). Avoid direct sunlight.

  • INACTIVE INGREDIENT

    Carbomer 934, Emu Oil, Arnica, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Benzyl Alcohol, Aqua.

  • PRINCIPAL DISPLAY PANEL

    numbing cream

  • INGREDIENTS AND APPEARANCE
    NUMBING CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85569-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    EMU OIL (UNII: 344821WD61)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85569-001-0150 g in 1 CARTON; Type 0: Not a Combination Product06/09/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/09/2025
    Labeler - 100 KARMA INC (120186232)
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