Label: CURACAINE TRANSDERMAL CORPORATION- lidocaine cream 

  • NDC Code(s): 51350-010-01, 51350-010-51
  • Packager: Transdermal Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/14

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  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine 4%

    PURPOSE:

    topical analgesic

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Uses for the temporary relief of

    • pain and itching
    • insect bites
    • sunburn
    • minor cuts
    • scrapes
    • burns
    • minor skin irritations

    Warnings

    For external use only

    When using this product

    • Keep out of eyes. Rinse with water to remove.
    • Do not use in large quantities, particularly over raw surfaces or blistered areas.
    • If pregnant or breast feeding, ask a health professional before use.

    Directions

    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

    Caprylyl Glycol, Cetearyl Alcohol, Clyclopentasiloxane, Deionized water, Dimethyl Sulone, Glycerin, Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Polysorbate 60, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium hyaluronate, Sodium Lauryl Sulfate Sulfate, Steric Acid, Tetrasodium EDTA, Tocopheryl Acetate, Sodium Hydroxide.

    Stop use and ask a doctor if conditions worsens, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of the product and consult a doctor.

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  • INGREDIENTS AND APPEARANCE
    CURACAINE  TRANSDERMAL CORPORATION
    lidocaine cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51350-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (LIDOCAINE) LIDOCAINE 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CAPRYLYL GLYCOL  
    CETOSTEARYL ALCOHOL  
    CYCLOMETHICONE 5  
    GLYCERIN  
    HEXYLENE GLYCOL  
    PHENOXYETHANOL  
    POLYSORBATE 20  
    POLYSORBATE 60  
    PROPYLENE GLYCOL  
    JOJOBA OIL  
    HYALURONATE SODIUM  
    SODIUM LAURYL SULFATE  
    EDETATE SODIUM  
    .ALPHA.-TOCOPHEROL ACETATE  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51350-010-51 1 in 1 BOX
    1 NDC:51350-010-01 30 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/12/2012
    Labeler - Transdermal Corp (963383612)
    Registrant - Transdermal Corp (963383612)
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