Label: AMERFRESH- sodium monofluorophosphate powder, dentifrice

  • NDC Code(s): 51460-1113-1, 51460-1113-2
  • Packager: Amercare Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.1 w/v fluoride ion)

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  • Purpose

    Anticavity toothpaste

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  • Use

    aids in the prevention of dental cavities

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  • 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.

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  • Directions For Use

    • wet toothbrush and dip into powder until brush is fully covered
    • brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly
    • 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 6 years of age: Do not use unless directed by a doctor or dentist
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  • Inactive ingredients

    calcium carbonate, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S.

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 57 g Packet Label

    AMERFRESH®
    FLUORIDE TOOTHPOWDER

    NET WT. 2 oz (57g)

    PRINCIPAL DISPLAY PANEL - 57 g Packet Label
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  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium monofluorophosphate powder, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51460-1113
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Monofluorophosphate (Fluoride Ion) Fluoride Ion 0.4332 g  in 57 g
    Inactive Ingredients
    Ingredient Name Strength
    calcium carbonate  
    carboxymethylcellulose sodium  
    saccharin sodium  
    sodium lauryl sulfate  
    hydrated silica  
    methylparaben sodium  
    propylparaben sodium  
    Product Characteristics
    Color PINK Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51460-1113-1 57 g in 1 PACKET
    2 NDC:51460-1113-2 446 g in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 12/20/2011
    Labeler - Amercare Products, Inc. (879289254)
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