Label: ALPHA-CAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 55346-0002-1
  • Packager: Dental Technologies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated March 10, 2016

If you are a consumer or patient please visit this version.

  • Active Ingredient:

    Benzocaine 20%

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  • Inactive Ingredients:

    PEG-8, PEG-75, Sodium Saccharin, Flavor, FD&C Blue #1, D&C Yellow #10.

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  • Indications for use:

    For oral Mucosal.


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  • Warning:

    Keep out of reach of children.

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  • Do not use

    if imprinted seal under cap is missing or broken.

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  • WARNINGS

    For professional use only.

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  • Principal Display Panel

    Dental Technologies

    www.dentaltech.com  

    ALPHA-CAINEā„¢

    Topical Anesthetic Gel

    Mint

    1 oz. (30g)

    REF 029.0201.002

    image of carton

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  • INGREDIENTS AND APPEARANCE
    ALPHA-CAINE  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-0002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55346-0002-1 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/1999
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 12/31/1999
    Labeler - Dental Technologies, Inc. (148312838)
    Registrant - Dental Technologies, Inc. (148312838)
    Establishment
    Name Address ID/FEI Business Operations
    Dental Technologies, Inc. 148312838 pack(55346-0002) , manufacture(55346-0002) , label(55346-0002)
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