Label: ORAJEL- sodium fluoride gel, dentifrice

  • NDC Code(s): 10237-775-42
  • 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 February 7, 2022

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  • ACTIVE INGREDIENT

    Sodium Fluoride (0.24%)

    (0.15% w/v fluoride ion)

  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE

    Aids in the prevention of dental decay

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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 denist or physician

  • INACTIVE INGREDIENT

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

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    JURASSIC WORLD

    Stage

    3

    2-10 YEARS

    Orajel™

    kids

    NATURALLY

    SOURCED*

    anti•cavity

    TOOTHPASTE

    fluoride

    NATURAL

    BERRY

    BLAST

    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)

    Orajel Jurassic Kids Toothpaste.jpg

  • INGREDIENTS AND APPEARANCE
    ORAJEL 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-775
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (Berry) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-775-42119 g in 1 TUBE; Type 0: Not a Combination Product07/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/20/2018
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-775)
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