Label: ORAJEL GABBYS DOLLHOUSE- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-914-42
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium fluoride (0.24%) (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental decay

  • 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.

  • Directions

    • twist off cap and remove foil seal
    • do not swallow
    • supervise children as necessary until capable of using without supervision
    adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
    children under 6 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • Inactive ingredients

    Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Natural Flavor, Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia). All inactive ingredients are described in the format "ingredient name (source)".

  • Questions or comments?

    Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at orajelkids.com

  • PRINCIPAL DISPLAY PANEL - 119 g Tube Label

    DREAMWORKS
    GABBY'S
    DOLLHOUSE

    STAGE
    2
    0-3
    YEARS

    Orajel™
    kids

    NATURALLY
    SOURCED*

    anti • cavity
    TOOTHPASTE
    fluoride

    NATURAL
    FRUITY
    BUBBLE

    OUR
    COMMITMENT

    CERTIFIED RENEWABLE ENERGY
    Green-e®

    PROUD SUPPORTER OF
    Arbor Day
    Foundation®

    PLASTIC
    TUBE

    how2recycle.info

    SCAN ME

    NET WT 4.2 OZ (119 g)

    PRINCIPAL DISPLAY PANEL - 119 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ORAJEL GABBYS DOLLHOUSE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-914
    Route of AdministrationORAL
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-914-42119 g in 1 TUBE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02101/01/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812MANUFACTURE(10237-914)
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