Label: CUTIECAINE (topical lidocaine- 4% w/w 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 April 27, 2011

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  • ACTIVE INGREDIENT

    Benzocaine 18% (w/w), Tetracaine 2% (w/w), Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g
  • 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
  • DO NOT USE

    •    Do not use in or near the eyes
    •    Do not 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.

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

    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.

     Do not use in or near the eyes
    •    Do not 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.

    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

    Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil, sodium lauryl sulfate,

    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
  • PRINCIPAL DISPLAY PANEL

    carton.jpg
    image of carton label
  • INGREDIENTS AND APPEARANCE
    CUTIECAINE 
    topical lidocaine (4% w/w) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50876-182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE180 mg  in 1 g
    TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE (UNII: V5VD430YW9)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50876-182-021 in 1 BOX
    1NDC:50876-182-0115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2010
    Labeler - Innovatech Inc (833205961)
    Registrant - Innovatech Inc (833205961)
    Establishment
    NameAddressID/FEIBusiness Operations
    Innovatech Inc 833205961manufacture, label, analysis, pack
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