Label: ORAL ANALGESIC- benzocaine and menthol paste

  • 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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  • ACTIVE INGREDIENT

    Active Ingredients          Purpose
    Benzocaine20%                  Oral pain reliever
    Menthol 0.25%                    Oral pain reliever
  • PURPOSE

    Use     for the temporary relief of pain due to:

    canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances

  • Warnings

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

    When using this product
    do not use more than directed
    do not use for more than 7 days unless directed by a doctor/dentist
    do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist

    Stop use and ask a doctor if
    sore mouth symptoms do not improve in 7 days
    irritation, pain or redness persists or worsens
    swelling, rash or fever develops

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


  • Directions

    Directions   

    remove cap and cut tip of the tube on score mark
    adults and children 2 years of age and over:  apply to tyhe affected area up to 4 times daily or as directed by doctor/dentist
    children under 12 years of age: should be supervised in the use of this product
    Children under 2 years of age:  ask a doctor/dentist

    Other information

    Do not use if tube tip is cut prior to opening.

    Inactive ingredients cellulose gum, gelatin, methyl salicylate, pectin, plasticized hydrdocarbon gel, polyethylene glycol, sodium saccharin
  • QUESTIONS

    Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm

  • PRINCIPAL DISPLAY PANEL

    meijer
    Oral Analgesic Paste
    maximum strength

    For Fast Relief of Oral Pain Caused by:
    Toothache, Denture, or Gum Irritations,
    Cold or Canker sores

    Oral Analgesic Paste
    maximum strength
    safety sealed tube tip

    MET WT. 0.21 oz (6g)



    carton image
    carton image

  • INGREDIENTS AND APPEARANCE
    ORAL ANALGESIC   MAXIMUM STRENGTH
    benzocaine and menthol paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-706
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GELATIN (UNII: 2G86QN327L)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PECTIN (UNII: 89NA02M4RX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-706-211 in 1 CARTON
    16.0 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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