Label: AMERFRESH FLUORIDE- sodium monofluorophosphate paste

  • 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 September 14, 2016

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  • Active Ingredient

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity toothpaste

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    If more than used for brushing is accidently swallowed, get medical help or contact a poison control center

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 yrs. of age

  • Directions

    • Adults and children 2 yrs. and older: Brush teeth throughtly after meals or at least twice a day or as directed by a dentist.
    • Do not swallow
    • To minimize swallowing, use a pea-sized amount in children under 6 years old.
    • Supervise children's brushing until good habits are established.
    • Children under 2 yrs.: ask a dentist before use.
  • Inactive Ingredients

    SODIUM MONOFLUOROPHOSPHATE, CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, CARBOXYMETHYLCELLULOSE, GLYCERIN, ALUMINUM HYDROXIDE, HYDRATED SILICA, POTASSIUM SORBATE, SODIUM LAURYL SULFATE, SORBITAN MONOOLEATE, SORBITOL, TITANIUM DIOXIDE, WATER, XANTHAN GUM.

  • AmerFresh Fluoride Gel Toothpaste

    image description

  • INGREDIENTS AND APPEARANCE
    AMERFRESH FLUORIDE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-3002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51460-3002-117 g in 1 TUBE; Type 0: Not a Combination Product09/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/12/2016
    Labeler - Amercare Products, Inc. (879289254)
    Registrant - Amercare Products, Inc. (879289254)
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