Label: ORAJEL FOR ALL MOUTH SORES MAXIMUM STRENGTH- benzocaine swab

  • NDC Code(s): 10237-709-12
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/10

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient          Purpose

    Benzocaine 20%                Oral Pain Reliever

    Uses for the temporary relief of pain associated with canker sores, cold sores, fever blisters minor irritation or injury of the mouth and gums

    Warnings
    Allergy Alert
    do not use this product if your have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

    Do not use
    more than directed, for more than 7 days unless told to do so by a dentist or doctor

    Stop use and ask a dentist of doctor if sore mouth symptoms do not get better in 7 days; swelling, rash or fever develops; irritation, pain or redness does not go away

    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

    Adults and Children               Hold swab with solid white tip down
    2 years of age and older        Bend and snap open swab tip with the colored rings
                                               Apply product to affected area
                                               Use up to 4 times daily or as directed by a dentist or doctor


    Other information do not use if label seal is broken prior to purchase, or if colored rings on tip are not orange
    Inactive ingredients flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

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

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  • PRINCIPAL DISPLAY PANEL

    Orajel Instant Pain Relief medicated swabs

    for all Mouth Sores

    Maximum Strength

    12 unit-dose Swabs  Net 0.06 FL OZ (1.8 ML) EACH

    Carton image

    Carton image

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  • INGREDIENTS AND APPEARANCE
    ORAJEL FOR ALL MOUTH SORES  MAXIMUM STRENGTH
    benzocaine swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10237-709
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 0.2 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL  
    WATER  
    FD&C RED NO. 40  
    SACCHARIN SODIUM  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-709-12 12 in 1 CARTON
    1 1.8 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 08/01/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    SwabPlus, Inc. 876441549 manufacture
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