Label: AMERFRESH- sodium monofluorophosphate powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 12, 2011

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  • SPL UNCLASSIFIED SECTION

    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 center 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

    Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 446 g Carton

    AMERFRESH®
    FLUORIDE TOOTHPOWDER

    NET WEIGHT 1 lb (446 g)

    Principal Display Panel - 446 g Carton
  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium monofluorophosphate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-0502
    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) 94.98 g  in 100 g
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Methylparaben Sodium (UNII: CR6K9C2NHK)  
    Propylparaben Sodium (UNII: 625NNB0G9N)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Ponceau 4R (UNII: Z525CBK9PG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51460-0502-1446 g in 1 POUCH
    2NDC:51460-0502-257 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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