Label: ORAJEL KIDSTOOTHPASTE- sodium fluoride paste, dentifrice

  • NDC Code(s): 10237-785-42
  • 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%

  • Purpose

    Anticavity toothpaste

  • Use

    aids in the prevention of dental decay

  • Warnings

    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 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 of physician
  • Inactive ingredients

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

  • Questions or comments?

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

  • 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.

  • Principal Display Panel

    Mixed Berry

    Orajel

    Anticavity

    Fluoride

    Toothpaste

    magical unicorns OR mermaid

    NET WT 4.2 OZ (119 g)

    CR_DA2039905_OJTU-43018-01-MER_72016734CR_DA2039904_OJTU-43018-01-UNI_72016735

  • INGREDIENTS AND APPEARANCE
    ORAJEL KIDSTOOTHPASTE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-785
    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
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-785-42119 g in 1 TUBE; Type 0: Not a Combination Product01/15/2020
    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(10237-785)
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