TRULY RADIANT REJUVENATING WHITENING (SODIUM FLUORIDE 0.243%) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]

TRULY RADIANT REJUVENATING WHITENING (SODIUM FLUORIDE 0.243%) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]
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NDC 10237-664-09, 10237-664-43
Set ID 0e1f5d7c-595a-3be7-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Church & Dwight Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART355
  • Drug Facts

    Active ingredient

    Sodium Fluoride 0.243%

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use

    aids in the prevention of dental decay

  • WARNINGS

    Warnings

    do not use if irritation occurs and persists.

  • 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

    • do not swallow
    • supervise children as necessary until capable of using without supervision
    • rinse away toothpaste residue thoroughly after brushing

    adults and children 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

    children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)

    children under 2 years - as a dentist or physician

  • INACTIVE INGREDIENT

    Inactive ingredients sodium bicarbonate (baking soda), hydrated silica, sorbitol, water, glycerin, tetrasodium pyrophosphate, sodium lauroly sarcosinate, flavor, sodium saccharin, cellulose gum, sodium lauryl sulfate, mica, titanium dioxide, blue 1, yellow 5

  • QUESTIONS

    Questions or comments? Call 1-800-786-5135 Mon.-Fri . 9am-5pm ET or visit www.TrulyRadiant.com

  • Principl Display AHFC-00016-01

    ARM AND HAMMER

    THE STANDARD OF PURITY

    Crisp Mint Twist NATURALLY POWERED BY BAKING SODA FLUORIDE ANTICAVITY TOOTHPASTE

    Rejuvenating

    Truly Radiant

    HELPS PREVENT STAINS ENAMEL SAFE WHITENING NEUTRALIZES ACID

    NET WT.

    4.3OZ (121g)

    DA2012161_AHFC-00016-06RJ_72013895.jpg

  • INGREDIENTS AND APPEARANCE
    TRULY RADIANT REJUVENATING  WHITENING
    sodium fluoride 0.243% paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-664
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Product Characteristics
    Colorblue (with Blue Twist) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-664-431 in 1 CARTON01/05/2015
    1121 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-664-091 in 1 CARTON02/02/201510/01/2019
    225 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2015
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-664)

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