Label: ORAJEL MAXIMUM STRENGTH- benzocaine liquid 

  • NDC Code(s): 10237-703-45
  • 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 03/11

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

  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20%

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  • PURPOSE

    Purpose

    Oral pain reliever

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  • INDICATIONS & USAGE

    Use for the temporary relief of pain due to toothaches

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  • WARNINGS

    Warnings

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


    Flammable keep away from fire or flame. Avoid smoking during application and until product has dried
                                                                                                                                                                                  

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  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a dentist or doctor                   
                                                                                                                                                                                        
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  • STOP USE

    Stop use and ask a doctor if

    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
    • symptoms do not improve in 7 days
                                                                                                                                                                                                  
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
                                                                                                                                                                                          

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  • DOSAGE & ADMINISTRATION

    Directions

    • remove imprinted safety seal from bottle cap
                                                                                                                                                                                                                                                                                        
    Adults and children 2 years and older                 Apply product with cotton swab or finger to the cavity and around gum surrounding the teeth.  Use up to 4 times daily or as directed by a dentist                                                                                                            or doctor 
                                                                                                                                                                                                                                                                                           

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

    Children under 2 years of age                            Ask a dentist or doctor
                                                                                                                                                                                                                                                                                                                       
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  • OTHER SAFETY INFORMATION

    Other information

    • do not use if imprinted bottle seal is broken or missing prior to opening
    • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
    • do not use continuously
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  • INACTIVE INGREDIENT

    Inactive ingredients  alcohol (54.6% by volume), flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

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  • QUESTIONS

    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


    #1 ORAL PAIN RELIEVER
         FOR TOOTHACHE


    Orajel                     liquid
    Instant Pain Relief


    for TOOTHACHE

    MAXIMUM STRENGTH
    NET CONTENTS 0.45 FL OZ (13.3 ML)     ORAL PAIN RELIEVER         BENZOCAINE 20%


    Carton imageCarton image

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  • INGREDIENTS AND APPEARANCE
    ORAJEL  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10237-703
    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
    ALCOHOL  
    POLYETHYLENE GLYCOL 400  
    SACCHARIN SODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-703-45 1 in 1 CARTON
    1 13.3 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 04/01/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    Accupac, Inc. 071609663 manufacture
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