ZIP TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL [GERMIPHENE CORPORATION]

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ZIP TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL [GERMIPHENE CORPORATION]
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NDC 61508-0201-1
Set ID 51dccfdb-a9c8-1d4f-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Germiphene Corporation
Generic Name
Product Class
Product Number
Application Number
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  • Use or purpose:

    For rapid topical anesthesia

  • ACTIVE INGREDIENT

    Medicinal ingredient: Benzocaine 20.0% w/w

  • PURPOSE

    Topical Anesthetic Gel

  • INACTIVE INGREDIENT

    Non-Medicinal Ingredients: 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 use only. 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, dificulty 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

    Caution: Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    30 g

  • INGREDIENTS AND APPEARANCE
    ZIP TOPICAL ANESTHETIC GEL MINT 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0201
    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
    WATER (UNII: 059QF0KO0R) 0.565 g  in 100 g
    POVIDONE (UNII: FZ989GH94E) 0.248 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 0.065 g  in 100 g
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 0.0249 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00155 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.00016 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.00016 g  in 100 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.697 g  in 100 g
    CARBOMER 934 (UNII: Z135WT9208) 3.086 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 43.29 g  in 100 g
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 30.62 g  in 100 g
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61508-0201-130 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(61508-0201)
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