Label: CVS ORAL ANESTHETIC- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL

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 July 8, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Benzocaine, 20%........................................Oral Anesthetic
  • PURPOSE



    Uses

    - temporary relieves pain associated with the following mouth and gum irritations:     
    - toothache  - canker sores   - sore gums    - braces    - dentures
    - minor dental procedures
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If more than is used for pain is accidentally
    swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE


    Uses

    - temporary relieves pain associated with the following mouth and gum irritations:     
    - toothache  - canker sores   - sore gums    - braces    - dentures
    - minor dental procedures
  • 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.

    When using this product

    - avoid contact with eyes
    - do not exceed recommended dosage
    - do not use for more than 7 days unless directed by a doctor/dentist

    Stop use and ask a dentist or a doctor if

    - sore mouth symptoms do not improve in 7 days
    - swelling, rash or fever develops
    - irritation, pain or redness persists or worsens

    Keep out of reach of children.    If more then used for pain is accidentally swallowed,
    get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION


    Directions

    - Adults and children 2 years of age and older: apply to the affected area
    - wipe liquid on with cotton, or cotton swab, or fingertip
    - apply up to 4 times daily or as recommended by a doctor/dentist

    - Children under 12 years of age: adult supervision should be given in the use of this product

    - children under 2 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    benzyl alcohol, D and C Yellow no 10, FD and C Blue no 1, FD and C Red no 40,
    flavor, methylparaben, polyethylene glycol, propylene glycol, saccharin
  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    CVS ORAL ANESTHETIC 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN (UNII: FST467XS7D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-186-511 in 1 CARTON
    130 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35607/08/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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