Label: AMERFRESH FLUORIDE- sodium fluoride 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 October 18, 2016

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  • Drug Facts

  • Active Ingredient

    Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

    Purpose

    Anticavity toothpaste

  • Use

    aids prevention of dental cavities

  • Warnings

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

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 yrs. and older:  Brush teeth thoroughly 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

    sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl paraben.

  • Package Labeling:

    LabelDrugFacts

  • INGREDIENTS AND APPEARANCE
    AMERFRESH FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-3030
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51460-3030-17.1 g in 1 PACKET; Type 0: Not a Combination Product10/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/12/2016
    Labeler - Amercare Products, Inc. (879289254)
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