Label: ORAL ANALGESIC- 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 May 13, 2010

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  • Uses

    Uses   temporarily relieves pain due to toothache, 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, benzocaine or other "caine" anesthetics.


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

    When using this product avoid contact with the eyes, do not use more than directed, for more than 7 days unless directed by a dentist or doctor

    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 imprinted safety seal from bottle cap

    Adults and children 2 years of age and over                  Apply product with cotton swab or clean fingertip to the affected area.
                                                                                     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 information     do not use if imprinted bottle seal is broken or missing prior to opening
  • Inactive ingredients

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

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Meijer

    Oral Analgesic Liquid
    maximum strength benzocaine 20%

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

    Oral Analgesic Liquid
    maximum Strength
    safety sealed tube tip

    NET WT. 0.45 OZ (13.3g)

    Carton Image
    Carton Image



  • INGREDIENTS AND APPEARANCE
    ORAL ANALGESIC   MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-703
    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)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-703-451 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 finalpart35605/13/2010
    Labeler - Meijer Distribution Inc. (006959555)
    Registrant - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac071609663manufacture
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