Label: CURACAINE- lidocaine hcl cream

  • Category: HUMAN OTC DRUG LABEL

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 February 14, 2017

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  • Active Ingredients

    LIDOCAINE HCL 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.

  • PURPOSE

    TOPICAL ANALGESIC

  • 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 UANTITIES, PARTICULARLY OVER RAW SURFACES OR BLISTERED AREAS.
  • STOP USE

    STOP USE AND ASK A DOCTOR IF CONDITION WORSENS, OR, IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A PISON CONTROL CENTER RIGHT AWAY.

  • PREGNANCY OR BREAST FEEDING

    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.

  • OTHER INFORMATION

    • STORE BETWEEN 58° - 87° F.
    • PROTECT FROM FREEZING, DIRECT HEAT OR SUNLIGHT.
  • QUESTIONS?

    CALL 248.341.3401 9AM-2PM CENTRAL

  • INACTIVE INGREDIENTS:

    CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, DEIONIZED WATER, DIMETHYL SULFONE, GLYCERIN, HEXYLENE GLYCOL, PHENOXYETHANOL, POLYSORBATE 20, POLYSORBATE 60, PROPYLENE GLYCOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, STEARIC ACID, TETRASODIUM EDTA, TOCOPHERYL ACETATE.

  • PRINCIPAL DISPLAY PANEL

    Curacaine_Label_Primary_Lidocaine HClCuracaine_REV 061915_r3

  • INGREDIENTS AND APPEARANCE
    CURACAINE 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51350-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51350-012-511 in 1 BOX09/12/2012
    1NDC:51350-012-1130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/12/2012
    Labeler - Transdermal Corp (963383612)
    Registrant - Transdermal Corp (963383612)
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