Label: ORAJEL SENSITIVITY RELIEF- sodium fluoride and potassium nitrate paste, dentifrice

  • NDC Code(s): 10237-678-12, 10237-678-43
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion)Anticavity
    Potassium Nitrate 5.0%Tooth Desensitizer
  • Use

    • Aids in the prevention of dental decay
    • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • Warnings

    Do not use if irritation occurs and persists.

    When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

    Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    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

    • Do not swallow
    • Supervise children as necessary until capable of using without supervision
    • Rinse away toothpaste residue thoroughly after brushing
    • Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
    • Children under 12 years of age: Consult a dentist or doctor.
  • Inactive ingredients

    Sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium saccharin

  • Questions or comments?

    Call 1-800-786-5135 Mon.–Fri. 9am–5pm ET or visit www.orajel.com

  • PRINCIPAL DISPLAY PANEL - 121.9 g Tube Carton

    NEW

    #1 ORAL PAIN RELIEF BRAND

    Orajel™

    Anticavity Toothpaste
    For Sensitive Teeth

    SOOTHING MINT

    SENSITIVITY RELIEF

    24/7 SENSITIVITY RELIEF TOOTHPASTE*

    Maxiumum sensitivity relief without a prescription
    Sensitivity protection from hot and cold

    NET WT 4.3 OZ (121.9 g)

    Principal Display Panel - 121.9 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ORAJEL SENSITIVITY RELIEF 
    sodium fluoride and potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-678
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.243 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-678-43121.9 g in 1 TUBE; Type 0: Not a Combination Product01/31/2024
    2NDC:10237-678-122 in 1 CARTON06/01/2024
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02101/31/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812MANUFACTURE(10237-678)
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