Label: WHITE GLO CHARCOAL SENSITIVE- potassium nitrate, sodium monofluorophosphate kit

  • NDC Code(s): 73656-011-00, 73656-012-00
  • Packager: WHITE GLO USA INC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 31, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredients

    Potassium nitrate 5%

    Sodium monofluorophospahte 0.76% (0.1% w/v fluoride ion)

    Purpose

    Antihypersensitivity

    Anticavity

  • Uses

    • Builds increasing protection against: painful sensitivity of the teeth to cold, heat, acids, sweets or contact. • Aids in the prevention of dental cavities.

  • Warnings

    When using this product,

    if irritation occurs discontinue use.

    Stop use and ask a dentist if

    • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use.

    Keep out of reach of children.

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

  • Directions

    • adults and children 12 years of age and older: • apply at least a 1-inch strip of the product onto a soft bristle toothbrush. • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. • Children under 12 years of age: Consult a dentist or doctor.


  • Other information

    • store below 30ºC (86ºF)

  • Inactive ingredients

    Sorbitol, hydrated silica, sodium lauryl sulfate, glycerin, water, cellulose gum, chondrus crispus (carrageenan), tetrasodium phosphate, sodium saccharin, sodium benzoate, bamboo charcoal

  • 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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    WHITE GLO CHARCOAL SENSITIVE 
    potassium nitrate, sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-011
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-011-001 in 1 KIT03/16/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOX 150 g
    Part 1 of 1
    WHITE GLO CHARCOAL SENSITIVE 
    potassium nitrate, sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:73656-012
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-012-001 in 1 TUBE
    1150 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/16/2020
    Labeler - WHITE GLO USA INC (117345666)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!