Label: CUTIECAINE - lidocaine hydrochloride cream 

  • Label RSS
  • NDC Code(s): 51350-111-01, 51350-111-02
  • 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 11/11

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  • ACTIVE INGREDIENT

    Cutiecaine-5%, Topical Lidocaine Cream (5% w/w),Active Ingredient; Lidocaine Hydrochloride 4% (w/w), Inactive Ingredients ; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

    for relief of pain and discomfort from; hemorrhoids pain and Itching, Other Uses; minor cuts, bruises, sun burn, insect bites, poison ivy, etc.

    Use for reducing pain or discomfort from;  hemorrhoids pain and Itching. minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy,  Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor

    Keep both used and unused medicine out of the reach of children or pets

    Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,SDS, Net Wt. 15g

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  • DOSAGE & ADMINISTRATION

    Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor Close
  • WARNINGS

    •    Do not use in or near the eyes
    •    Do use in large amount particularly over the raw surfaces or blisters
    Stop use and Ask Doctors if
    •    Allergic reactions occurs
    •    Condition worsen and does not improve
    •    Symptoms clean up and returns within few day
    •    itching, redness, burning , swelling or other symptoms occurs
    •    Keep both used and unused medicine out of the reach of children or pets
    •    If swallowed get medical attention right away Call your doctor immediately.
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  • PRINCIPAL DISPLAY PANEL

    carton.jpg
    image of carton label
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  • INGREDIENTS AND APPEARANCE
    CUTIECAINE 
    topical lidocaine (5% w/w) cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51350-111
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CARBOMER HOMOPOLYMER TYPE C  
    GLYCERIN  
    STEARIC ACID  
    SODIUM LAURYL SULFATE  
    ISOPROPYL ALCOHOL  
    CETYL ALCOHOL  
    ALCOHOL  
    ALOE  
    HYALURONATE SODIUM  
    POLYSORBATE 20  
    BUTYLENE GLYCOL  
    CASTOR OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51350-111-02 1 in 1 CARTON
    1 NDC:51350-111-01 15 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/15/2011
    Labeler - Transdermal Corp (963383612)
    Registrant - Transdermal Corp (963383612)
    Establishment
    Name Address ID/FEI Business Operations
    Transdermal Corp 963383612 manufacture, label, analysis, pack
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