Label: AMERFRESH- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 16, 2011

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  • SPL UNCLASSIFIED SECTION

    FLUORIDE TOOTHPASTE

  • DRUG FACTS

  • Active ingredient

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

  • Purpose

    Anticavity

  • Use

    helps protect against 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 centre immediately.

  • Directions

    Adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.
    Children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
    Children under 2 yearsAsk a dentist or physician.
  • Inactive Ingredients

    Sorbitol, Silica, Calcium Carbonate, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin,Treated water, SCMC, Sodium Lauryl Sulfate.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 141 g Carton Label

    AMERFRESH®

    FLUORIDE TOOTHPASTE

    NET WT. 5 oz (141g)

    PRINCIPAL DISPLAY PANEL - 141 g Carton Label
  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-5000
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Sodium Monofluorophosphate0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Carbonate (UNII: H0G9379FGK) 42 g  in 100 g
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Methylparaben Sodium (UNII: CR6K9C2NHK)  
    Propylparaben Sodium (UNII: 625NNB0G9N)  
    Product Characteristics
    ColorWHITEScorescore with uneven pieces
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51460-5000-1141 g in 1 TUBE
    2NDC:51460-5000-285 g in 1 TUBE
    3NDC:51460-5000-342 g in 1 TUBE
    4NDC:51460-5000-424 g in 1 TUBE
    5NDC:51460-5000-517 g in 1 TUBE
    6NDC:51460-5000-64.24 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/01/1996
    Labeler - Amercare Products Inc (879289254)
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