Label: WALGREENS PEROXIDE WHITENING- sodium monofluorophosphate paste, dentifrice 

  • Label RSS
  • NDC Code(s): 0363-8201-12, 0363-8201-19
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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  • Active ingredient

    Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)..................................Purpose: Anticavity

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  • Uses

    aids in the prevention of dental caviites

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  • WARNINGS

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

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

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  • Directions

    Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.

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  • Other Information

    Store in a cool dry place. Keep tube capped when not in use.

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  • Inactive ingredients

    glycerin, dicalcium phosphate, PEG-12, PVP, PEG/PPG 116/66 copolymer, hydrated silica, hydrogen peroxide, propylene glycol, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

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  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.

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  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

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  • INGREDIENTS AND APPEARANCE
    WALGREENS  PEROXIDE WHITENING
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-8201
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.76 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    SODIUM PYROPHOSPHATE  
    POLYETHYLENE GLYCOL 600  
    PROPYLENE GLYCOL  
    SACCHARIN SODIUM  
    SUCRALOSE  
    BUTYLATED HYDROXYTOLUENE  
    PEG/PPG-116/66 COPOLYMER  
    PHOSPHORIC ACID  
    HYDRATED SILICA  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (L Menthol) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-8201-19 1 in 1 CARTON
    1 NDC:0363-8201-12 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 10/01/2012
    Labeler - Walgreens (008965063)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(0363-8201), pack(0363-8201)
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