Label: ADVANCE WHITE TARTAR CONTROL BREATH FRESHENING- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-656-09, 10237-656-43, 10237-656-60, 10237-656-72
  • Packager: Church & Dwight Co., Inc.
  • 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 18, 2023

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  • ACTIVE INGREDIENT

    Active ingredients        
    Sodium fluoride (0.24%)

  • PURPOSE

    Purpose
    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use    aids in the prevention of dental decay   

  • KEEP OUT OF REACH OF CHILDREN

    Warning

    Keep out of reach of children under 6 years of age.


  • 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           do not swallow    supervise children as necessary until capable of using without supervision

    adults and children 2 years and older           brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician
    children under 6 years                                    instruct in good rushing and rinsing habits (to minimize swallowing)
    children under 2 years                                    consult a dentist or physician

  • INACTIVE INGREDIENT

    Inactive ingredients   water, sodium bicarbonate (baking soda), sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, flavor, sodium saccharin, cellulose gum, sodium lauroyl sarcosinate, sodium lauryl sulfate, titanium dioxide

  • QUESTIONS

    Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET or visit www.myoralcare.com

  • Principal Display Panel

    ARM AND HAMMER

    The Standard of Purity

    Winter Mint NATURALLY POWERED BY BAKING SODA Fluoride Anticavity Toothpaste

    AdvanceWhite

    BREATH FRESHENING

    LASTS FOR HOURS PROVEN WHITENING NEUTRALIZES ACID

    NET WT. 6.0OZ. (170g)

    DA2012158_AWFC-18623-07

    DA2012158_AWFC-18623-07

  • INGREDIENTS AND APPEARANCE
    ADVANCE WHITE   TARTAR CONTROL BREATH FRESHENING
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-656
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Fresh Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-656-091 in 1 CARTON01/29/201909/23/2019
    125 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-656-431 in 1 CARTON01/29/201209/23/2019
    2121 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10237-656-601 in 1 CARTON09/23/2019
    3170 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:10237-656-721 in 1 CARTON01/29/201209/23/2019
    4204 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/29/2012
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-656)
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