Label: AMERFRESH CLEAR- sodium fluoride 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 March 16, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    FLUORIDE gel TOOTHPASTE

  • DRUG FACTS

  • Active ingredient

    Sodium Fluoride 0.22% (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 Ingredient

    Sorbitol, Silica, 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 - 181 g Carton Label

    AMERFRESH®

    FLUORIDE gel TOOTHPASTE

    NET WT. 6.4 oz (181g)

    PRINCIPAL DISPLAY PANEL - 181 g Carton Label
  • INGREDIENTS AND APPEARANCE
    AMERFRESH CLEAR 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-5010
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R) 64 g  in 100 g
    Water (UNII: 059QF0KO0R)  
    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:51460-5010-185 g in 1 TUBE
    2NDC:51460-5010-242 g in 1 TUBE
    3NDC:51460-5010-324 g in 1 TUBE
    4NDC:51460-5010-417 g in 1 TUBE
    5NDC:51460-5010-5181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/01/1996
    Labeler - Amercare Products Inc (879289254)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!