Label: STANGARD- topical snf fluoride gel gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated December 19, 2022

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  • Active Ingredient:

    Active Ingredient: Stannous Fluoride 0.4%

    Purpose: Anticavity

  • Warnings:

    This is an anticavity preventive treatmeng gel, not a toothpaste.

    Read directions carefully before using

    Keep out of reach of children

    If more than amount used for brushing is swallowed, seek professional assistance or contact a Poison Control Center immediately.

    Do not use if foil seal is missing or damaged.

  • Directions

    Adults and children 6 years of age and older:

    Before dispensing, remove cap and peel off seal

    Use once daily after brushing with toothpaste

    Apply a small amount of gel totoothbrush and brush teeth thoroughly

    Allow the gel to remain on teeth for one minute

    Spit out the gel. Do not swallow.

    Do not eat, drink or rinse for 30 minutes after brushing

    Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without adult supervision.

    Children under age 6: Consult a dentist or physician.

  • Inactive Ingredients

    Glycerin, carbomer 940, natural and artificial flavors

  • Other Information:

    Store at 15-30°C (59-86ºF)

    Keep tightly closed when not in use

    Expiration Date can be found on tube crimp

  • StanGard

    Stangard Topical Stannous Fluoride GelStanGard Preventive Treatment Gel Mint Flavor 11-650

  • INGREDIENTS AND APPEARANCE
    STANGARD 
    topical snf fluoride gel gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0271
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION3.8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 12.56 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10866-0271-1122 g in 1 TUBE; Type 0: Not a Combination Product04/01/1981
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only04/01/1981
    Labeler - Pascal Company, Inc. (009260217)
    Registrant - Pascal Company, Inc. (009260217)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pascal Company, Inc.009260217manufacture(10866-0271)
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