Label: WHITE GLO BIO-ENZYME- sodium monofluorophosphate kit

  • NDC Code(s): 73656-005-00, 73656-006-00
  • Packager: WHITE GLO USA INC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 27, 2023

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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.

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

  • 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

    sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, xylitol, flavor, cellulose gum, sodium benzoate, sodium ascorbyl phosphate, tocopherol acetate, bromelain, papain, menthol

  • Questions or comments

    For customer enquiries, please contact: customer.enquiry@whiteglo.com White Glo USA INC.25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

  • Pcakage Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    WHITE GLO BIO-ENZYME 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-005
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-005-001 in 1 KIT02/15/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 150 g
    Part 1 of 1
    WHITE GLO BIO-ENZYME 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:73656-006
    Route of AdministrationDENTAL
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BROMELAINS (UNII: U182GP2CF3)  
    PAPAIN (UNII: A236A06Y32)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-006-00150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/15/2020
    Labeler - WHITE GLO USA INC (117345666)
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