Label: ORAL ANALGESIC MAXIMUM STRENGTH- oral pain reliever gel

  • 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 May 13, 2010

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  • Uses

    Uses    temporarily relieves pain associated with:

    toothache         minor dental procedures

    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.

    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 physician if    swelling, rash or fever develops; irritation, pain or redness persists or worsens


    Keep out of reach of children:

    in case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions  

    do not use if tube is cut prior to opening;  cut open tip of tube on score mark

    Adults and children 2 years of age and over                  Apply a small amount of product to the cavity and around gum surrounding the teeth.
                                                                                     Use up to 4 times daily or as directed by a dentist or physician

    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 information      This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.
  • Inactive ingredients

    Inactive ingredients  flavor, polyethylene glycol, sodium saccharin, sorbic acid

  • 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

    Orajel         gel

    Instant Pain Relief

    for TOOTHACHE

    MAXIMUM STRENGTH



    NE WT 0.42 OZ (11.9 g)     ORAL PAIN RELIEVER   BENZOCAINE 20%


    carton image
    carton image

  • INGREDIENTS AND APPEARANCE
    ORAL ANALGESIC  MAXIMUM STRENGTH
    oral pain reliever gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    polyethylene glycol (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    sorbic acid (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-701-251 in 1 CARTON
    17.1 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/13/2010
    Labeler - Meijer Distribution, Inc. (006959555)
    Registrant - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture
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