Label: ORAJEL FLUORIDE- sodium fluoride gel, dentifrice

  • 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 October 24, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Sodium Fluoride (0.24%)

  • PURPOSE

    Anticavity Toothpaste

  • Use

    Aids in the prevention of dental decay

  • WARNINGS

    Warnings

    Keep our of reach of children under 6 years of age

    If more than used for brushing is accidently 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. If more than used for brushing is accidently 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 or physician

  • INACTIVE INGREDIENT

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

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Bubble Berry

    Orajel

    Anticavity

    Fluoride

    Toothpaste

    Disney

    Elena

    Avalor

    NET WT 4.2 OZ (119g)

    OJTU-00017-01 (002).jpg

  • INGREDIENTS AND APPEARANCE
    ORAJEL FLUORIDE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-773
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorBERRY (Bubble Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-773-421 g in 1 TUBE; Type 0: Not a Combination Product10/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/24/2017
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-773)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!