Label: HEB BRILLIANT WHITE- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Uses aids in the prevention of dental caviites

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older: brush teeth thorughly 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 avoid swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Children under 2 years of age: consult a dentist or doctor.
  • INACTIVE INGREDIENT

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

  • STORAGE AND HANDLING

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

  • 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

    H-E-B®

    Dazzling Mint

    BRILLIANT WHITE

    FLUORIDE ANTICAVITY TOOTHPASTE

    NET WT. 5 OZ (141.7 g)

    HEB BRILLIANT WHITE 2821228R3

  • INGREDIENTS AND APPEARANCE
    HEB   BRILLIANT WHITE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-896
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (L Menthol) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-896-691 in 1 CARTON10/01/201202/21/2019
    1156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37808-896-291 in 1 CARTON02/21/2019
    2141.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/01/2012
    Labeler - HEB (007924756)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(37808-896)
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