Label: AMERFRESH- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 7, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    aids in the prevention of dental cavities

  • Warning

    Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • do not swallow
    • supervise children as necessary until capable of using without supervision
    • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
    • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
    • Children under 2 years of age: Consult a dentist or doctor
  • Inactive ingredients

    sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl Paraben.

  • SPL UNCLASSIFIED SECTION

    Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226.

  • PRINCIPAL DISPLAY PANEL - 85g Tube Label

    AMERFRESH®

    FLUORIDE Gel TOOTHPASTE
    NET WT. 3 oz (85g)

    PRINCIPAL DISPLAY PANEL - 85g Tube Label
  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-1111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.187 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Methylparaben Sodium (UNII: CR6K9C2NHK)  
    Propylparaben Sodium (UNII: 625NNB0G9N)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51460-1111-185 g in 1 TUBE
    2NDC:51460-1111-27.1 g in 1 PACKET
    3NDC:51460-1111-317 g in 1 TUBE
    4NDC:51460-1111-424 g in 1 TUBE
    5NDC:51460-1111-543 g in 1 TUBE
    6NDC:51460-1111-6130 g in 1 TUBE
    7NDC:51460-1111-7181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/14/2012
    Labeler - Amercare Products, Inc. (879289254)
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