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Orajel Antiseptic Rinse for Mouth Sores (Church & Dwight Co., Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 473.2 mL in 1 BOTTLE (10237-720-16) Label Information

Complete Orajel Antiseptic Rinse for Mouth Sores Information

  • ACTIVE INGREDIENT

    Active ingredient                 Purpose

    hydrogen peroxide 1.5%      Oral debriding agent

    Uses for temporary use in cleansing minor wounds or minor gum inflammation resulting form:
    minor dental procedures      accidental injury
    orthodontic appliances         canker sores
    dentures                            other irritations of the mouth and gums

    Aids in the removal of  phlegm, mucus, other secretions associated with occasional sore mouth

    Warnings

    Do not use this product for more than 7 days unless directed by a dentist or doctor

    When using this product do not swallow

    Stop use and see your dentist or doctor promptly if  swelling, rash or fever develops;' irritations, pain or redness persists or worsens; sore mouth symptoms do not improve in 7 days


    Keep out of reach of children. in case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away



    Directions remove imprinted safety seal from bottle cap; to remove child-resistant cap, squeeze smooth sides of cap while turning.  Reclose tightly. Ready to use, no mixing needed

    Adults and children                       Swish one-half capful (2teaspoons - 10mL) around the    
    2 years of age and older                mouth over the affected area for at least 1 minute and                                                        Then spit out.  Use up to 4 times daily after meals and at                                                    bedtime or as directed by a dentist or doctor

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

    Children under 2 years of age        Consult a dentist or doctor        



    Other information  cap tightly; keep away from heat or direct sunlight; do not use if safety seal is broken or missing

    Inactive ingredients  alcohol (4.1% by volume), blue 1, disodium EDTA, methylparaben, methyl salicylate, phosphoric acid, poloxamer 338, purified water, sodium saccharin, sorbitol

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


  • PRINCIPAL DISPLAY PANEL

    Orajel Anti-Bacterial Rinse

    fro Bleeding Gums

    Label imageLabel image


  • INGREDIENTS AND APPEARANCE
    ORAJEL ANTISEPTIC RINSE FOR MOUTH SORES 
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-720
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    hydrogen peroxide (UNII: BBX060AN9V) (hydrogen peroxide - UNII:BBX060AN9V) hydrogen peroxide .015 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-720-16 473.2 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 07/29/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    Accupac, Inc. 071609663 manufacture