Label: HEB GLEAMING WHITE ARCTIC MINT- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 14, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride 0.243% (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Usesaids in the prevention of dental cavities

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

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

    • 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 supervision.
    • Children under 2 years of age: consult a dentist or doctor.
  • STORAGE AND HANDLING

    Other information Store in a cool, dry place. · Keep tube capped when not in use.

  • INACTIVE INGREDIENT

    Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

  • QUESTIONS

    Questions or comments?CALL 1-877-777-2743

  • SPL UNCLASSIFIED SECTION

    MADE WITH PRIDE AND CARE FOR H-E-B®

    SAN ANTONIO, TX 78204

  • PRINCIPAL DISPLAY PANEL

    HEB®

    GLEAMING WHITE

    FLUORIDE ANTICAVITY TOOTHPASTE

    Arctic Cool Mint

    NET WT. 4.8 OZ (136 g)

    HEB GLEAMING WHITE ARCTIC 2821264

  • INGREDIENTS AND APPEARANCE
    HEB GLEAMING WHITE  ARCTIC MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-320
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    MICA (UNII: V8A1AW0880)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-320-591 in 1 BOX02/19/2019
    1136 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/12/2019
    Labeler - HEB (007924756)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(37808-320)
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