Label: CHARM TEX- 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 December 29, 2011

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Sodium monofluorophosphte 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 centre immediately.

  • Inactive ingredient

    Sorbitol, Silica, Calcium Carbonate, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin,Treated water, SCMC, Sodium Lauryl Sulfate.

  • Directions

    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 physician.

    Children 2 to 6 years

    Use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.

    Children under 2 years

    Ask a dentist or physician.

  • SPL UNCLASSIFIED SECTION

    Exclusive Distributor: Charm-Tex, Inc. USA

  • PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube Label

    Charm-Tex

    FLUORIDE TOOTHPASTE

    Net Wt. 1.5 oz.
    42.5 Grams

    PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube Label
  • INGREDIENTS AND APPEARANCE
    CHARM TEX 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40057-1000
    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) 42 g  in 100 g
    Sorbitol (UNII: 506T60A25R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Saccharin Sodium Dihydrate (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:40057-1000-1141 g in 1 TUBE
    2NDC:40057-1000-285 g in 1 TUBE
    3NDC:40057-1000-342.5 g in 1 TUBE
    4NDC:40057-1000-424 g in 1 TUBE
    5NDC:40057-1000-517 g in 1 TUBE
    6NDC:40057-1000-64.24 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/01/2011
    Labeler - Charm Tex, Inc. (058347543)
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!