Label: ORAJEL COMPLETE PROTECTION- sodium fluoride paste

  • NDC Code(s): 10237-677-12, 10237-677-43
  • 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

    Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, flavor, sodium lauryl sulfate, sodium saccharin, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide

  • 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

    DEEP CLEAN MINT

    COMPLETE PROTECTION

    DEEP CLEANING SENSITIVE TOOTHPASTE

    Gently whitens and strengthens enamel
    Helps remove plaque bacteria

    NET WT 4.3 OZ (121.9 g)

    PRINCIPAL DISPLAY PANEL - 121.9 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ORAJEL COMPLETE PROTECTION 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-677
    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)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-677-431 in 1 CARTON01/01/2024
    1121.9 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-677-122 in 1 CARTON05/01/2024
    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 DRUGM02101/01/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812MANUFACTURE(10237-677)
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