Label: ZIP TOPICAL ANESTHETIC GEL STRAWBERRY- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 14, 2017

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  • INDICATIONS & USAGE

    For rapid topical anesthesia

  • PURPOSE

    For rapid topical anesthesia

  • ACTIVE INGREDIENT

    Medicinal Ingredients: Benzocaine 20% w/w

  • INACTIVE INGREDIENT

    Propylene glycol, polyethylene glycol, carbomer, povidone, sodium saccharin, flavouring and colouring agents. (mint flavour only: ethyl alcohol, methyl paraben, propyl paraben.)

  • DOSAGE & ADMINISTRATION

    Directions: Apply approximately 0.2 mL of gel to the desired area using a cotton swab. For adults and children 2 years of age or older. For professional useonly. Use only on the advice of a physician.

  • WARNINGS

    Warning: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water. Stop use and consult a health-care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. Use smallest amount possible to achieve desired result. Do not use if allergic to benzocaine or any other ingredients in the product. Use with caution in children. Do not use if tamper-evident foil seal is broken. do not store in direct sunlight. Do not swallow.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    30 g

  • INGREDIENTS AND APPEARANCE
    ZIP TOPICAL ANESTHETIC GEL STRAWBERRY 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0202
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.002 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 43.7 g  in 100 g
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 30.75 g  in 100 g
    POVIDONE (UNII: FZ989GH94E) 0.25 g  in 100 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.7 g  in 100 g
    CARBOMER 934 (UNII: Z135WT9208) 3.1 g  in 100 g
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61508-0202-130 g in 1 JAR; Type 0: Not a Combination Product06/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/16/2017
    Labeler - Germiphene Corporation (206412512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Germiphene Corporation206412512manufacture(61508-0202)
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