Label: ORAJEL FLUORIDE- sodium fluoride gel, dentifrice

  • NDC Code(s): 10237-763-42
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL

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%)

  • PURPOSE

    Anticavity Toothpaste

  • INDICATIONS & USAGE

    Use aids in the prevention of dental decay

  • WARNINGS

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

  • KEEP OUT OF REACH OF CHILDREN

    If more than used for brushing is accidently 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 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 - ask a dentist or physician

  • INACTIVE INGREDIENT

    sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1

  • QUESTIONS

    Questions or comments Call us at 800 952 5080 Monday through Friday 9 - 5 ET or visit our website at www orajel com

  • PRINCIPAL DISPLAY PANEL

    Berry Divine

    Orajel ™

    Anticavity

    Fluoride

    Toothpaste

    Shimmer and Shine

    NET WT. 4.2 OZ (119g)

    Nickelodeon

    OJTU-42999-01

  • INGREDIENTS AND APPEARANCE
    ORAJEL FLUORIDE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-763
    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
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorBERRY (Berry Devine) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-763-42119 g in 1 TUBE; Type 0: Not a Combination Product12/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/10/2016
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812MANUFACTURE(10237-763)
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