Label: ORAJEL KIDS MY WAY ANTICAVITY TOOTHPASTE- sodium fluoride gel, dentifrice

  • 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 March 24, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride (0.24%)

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use aids in the prevention of dental decay

  • WARNINGS

    Warnings

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

  • DOSAGE & ADMINISTRATION

    Directions

    • 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 doctor
  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    Inactive ingredients sorbitol, water, hydrated silica, PEG-32, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1.

  • QUESTIONS

    Question or comments?  Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

  • Principal Display Carton OJKFC-32370-01

    Orajel Kids
    My Way

    Anticavity Fluroide Toothpaste

    Over 100 Stickers Inside
    Decorate Your Toothpaste Your Way

    Fruit Burst Flavor

    WARNING:
    CHOKING HAZARD-
    Small parts. Not for                    NEW WT 3 OZ (85g)
    children under 3 years.

    Carton image
    Carton image
  • INGREDIENTS AND APPEARANCE
    ORAJEL  KIDS MY WAY ANTICAVITY TOOTHPASTE
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-728
    Route of AdministrationDENTAL
    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)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUIT (FRUIT BURST FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-728-301 in 1 CARTON
    185 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2011
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc.071609663manufacture
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