Label: ORAJEL MAXIMUM STRENGTH- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 15, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20%

  • PURPOSE

    Purpose

    Oral pain reliever

  • INDICATIONS & USAGE

    Use for the temporary relief of pain due to toothaches

  • 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
                                                                                                                                                                                  

  • DO NOT USE

    Do not use

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

  • 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
                                                                                                                                                                                                                                                                                                                       
  • 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
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    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


    #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

  • INGREDIENTS AND APPEARANCE
    ORAJEL  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-703
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine0.2 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-703-451 in 1 CARTON
    113.3 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/01/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc.071609663manufacture
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