Label: SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA- 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 October 4, 2012

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  • Spearmint and Peppermint PLAQUE A WAY Fluoride Anticavity Toothpaste Gentle Formula


  • Active Ingredient

    Sodium fluoride 0.24% (0.14 w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warnings


    Keep out of reach of children under 6 years 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 years and over
    		Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    children under 6 years of age
    		Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without a supervision.
    children under 2 years of age
    		Consult a dentist or doctor.
  • Inactive Ingredients

    WATER, DICALCIUM PHOSHATE, SORBITOL, GLYCERIN, SODIUM LAURYL SULFATE, ANNATTO ( BIXA ORELLANA) SEED EXTRACT, SODIUM HYDROXIDE, NATURAL AND ARTIFICIAL FLAVORS, DISODIUMM EDTA, CELLULOSE GUM, SODIUM SACCHARIN, TETRASODIUM PYROPHOSPHATE, FD AND C BLUE NO.1

  • Spearmint and Peppermint PLAQUE A WAY Fluoride Anticavity Toothpaste Gentle Formula 116g (42288-000-04)


    PlaqueAWayFrontLabel

    PlaqueAWayBackLabel

  • INGREDIENTS AND APPEARANCE
    SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA   GENTLE FORMULA
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42288-000
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINT (SPEARMINT) , PEPPERMINT (PEPPERMINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42288-000-04116 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/03/2012
    Labeler - SLH Optimal Health LLC (031081015)
    Registrant - SLH Optimal Health LLC (031081015)
    Establishment
    NameAddressID/FEIBusiness Operations
    SLH Optimal Health LLC031081015manufacture(42288-000)
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