Label: ORAJEL PAW PATROL- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-786-42
  • 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 January 10, 2023

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  • ACTIVE INGREDIENT

    Sodium fluoride 0.24%

    (0.15% w/v fluoride ion)

  • PURPOSE

    Anticavity toothpaste

  • INDICATIONS & USAGE

    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.

    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

    • 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 years ask a dentist or physician

  • INACTIVE INGREDIENT

    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 www.orajelkids.com

  • PRINCIPAL DISPLAY PANEL

    nickelodeon™

    PAW

    PATROL

    STAGE

    3

    2-10 YEARS

    Orajel™

    kids

    NATURALLY

    SOURCED*

    anti · cavity

    TOOTHPASTE

    fluoride

    NATURAL

    FRUITY

    BUBBLE

    NET WT 4.2 OZ (119 g)

    Orajel Paw Patrol FC.jpg

  • INGREDIENTS AND APPEARANCE
    ORAJEL PAW PATROL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-786
    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
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-786-42119 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/01/2019
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812MANUFACTURE(10237-786)
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