Label: AMERFRESH- sodium monofluorophosphate paste, dentifrice

  • 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 January 15, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (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 6 years of age: Do not use unless directed by a doctor or dentist
  • Inactive ingredients

    calcium carbonate, water, sorbitol, 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 - 85 g Tube Label - NDC 51460-1112

    AMERFRESH®

    FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1112
  • PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1114

    AMERFRESH®

    FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1113
  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-1112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Carbonate (UNII: H0G9379FGK)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    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:51460-1112-185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51460-1112-27.1 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:51460-1112-31 in 1 BOX
    385 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:51460-1112-417 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:51460-1112-524 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:51460-1112-643 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:51460-1112-71 in 1 BOX
    743 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:51460-1112-8130 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:51460-1112-9181 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:51460-1112-0142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/14/2012
    AMERFRESH 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-1114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Carbonate (UNII: H0G9379FGK)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    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:51460-1114-085 g in 1 TUBE; Type 0: Not a Combination Product
    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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