Label: THERABREATH TOOTHPASTE- sodium fluoride gel, 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 3, 2010

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  • INDICATIONS & USAGE

    Directions: Cover the bristles of a dry tooth brush with TheraBreath Toothpaste and brush teeth, tongue, and palate for 2 minutes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • GENERAL PRECAUTIONS

    If spilled on fabrics, wash out immediately. This product was sealed with protective packaging at the laboratory. If seal is missing, do not use.
  • PRINCIPAL DISPLAY PANEL

    Naturally Oxygenating

    Professional Formula
    TheraBreath
    Dentist Recommended
    Fresh Breath
    Toothpaste

    No Sodium Lauryl Sulfate
    With Aloe Vera for Health Gums
    Works Instantly - Reverses Dry Mouth
    24 HR Confidence Guaranteed
    THERABREATH TUBE

  • INGREDIENTS AND APPEARANCE
    THERABREATH TOOTHPASTE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-033
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE24 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    ALOE (UNII: V5VD430YW9)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINT (PEPPERMINT OIL) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57367-033-18113.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/03/2010
    Labeler - 220 LABORATORIES INC (783247950)
    Registrant - 220 LABORATORIES INC (783247950)
    Establishment
    NameAddressID/FEIBusiness Operations
    220 LABORATORIES INC783247950manufacture
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