Label: WHITE GLO ADVANTAGE ANTICAVITY FLUORIDE PURPLE- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2024

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  • Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.76% (0.1% W/V Fluoride ion).

    Purpose

    Anticavity toothpaste

  • Use

    helps protect against 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 of age & older:     		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 in good brushing and rinsing habits
    (to minimize swallowing). Supervise children as
    necessary until capable of using without supervision.

    Children under 2 years of age: Consult a dentist or doctor.

  • Other information

    • Store in a cool place, below 86° F, away from heat
    • Do not use if quality seal is broken or missing
  • Inactive ingredients

    Calcium Carbonate, Aqua, Glycerin, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Aroma, Sodium Monofluorophosphate, Cellulose Gum, Mentholum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, D&C Red No.33, FD&C Blue No.1

  • Questions or comments

    For customer enquiries, please contact: customer.service@whiteglo.com White Glo USA INC. 42 West Campbell Avenue, Third Floor, Campbell, California, 95008. www.whiteglo.com

  • Package Labeling:

    Label.jpgTube Label

  • INGREDIENTS AND APPEARANCE
    WHITE GLO ADVANTAGE ANTICAVITY FLUORIDE PURPLE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-026-001 in 1 BOX04/20/2024
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/20/2024
    Labeler - WHITE GLO USA INC (117345666)
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