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Orajel Dry Mouth Moistruizing (Church & Dwight Co., Inc.)

Available Formats

Dosage Form Package Information Links
GEL 1 TUBE in 1 CARTON (10237-719-15) > 42 g in 1 TUBE Label Information

Complete Orajel Dry Mouth Moistruizing Information

  • ACTIVE INGREDIENT


    Active ingredient               Purpose

    Glyercin 18%                           Oral demulcent

    Use for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

    Warnings

    Keep out of the reach of children. If an excessive amount of gel is accidentally swallowed, get medical help or contact a Poison Control Center right away.  If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.  If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

    Directions   use as needed or as directed by a dentist or doctor
                          puncture safety seal with opposite end of tube cap
                          do not use if safety seal is damaged or mission prior to first use

    Adults and children 2 years            Apply a one-inch strip of product directly to tongue and around of age and older                            the inside and outside of the tooth and gum surface.  Do not                                                        rinse out.

    Children under 12 years of age      Should be supervised in the use of this product

    Children under 2 years of age        Consult a dentist or doctor



    Inactive ingredients  calcium disodium EDTA, citric acid, disodium phosphate, flavor, methylparaben, propylparaben, purified water, sorbitol, sucralose, Thinone Complex (a patented proprietarey blend of antioxidants, xanthan gum.

    Questions or comments:  Call us at 1-800952-5080 M-F 9am-5pm ET or visit our webiste at www.orajel.com


  • PRINCIPAL DISPLAY PANEL

    Carton image

    Carton image


  • INGREDIENTS AND APPEARANCE
    ORAJEL DRY MOUTH MOISTRUIZING 
    glycerin gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-719
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 180 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-719-15 1 in 1 CARTON
    1 42 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 07/21/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    Church & Dwight Co., Inc. 043690812 manufacture