Label: CVS ORAL ANESTHETIC - benzocaine liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/10

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

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



    Uses

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

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  • 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.

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  • INDICATIONS & USAGE


    Uses

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

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  • 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. Close
  • 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


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  • 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 Close
  • INGREDIENTS AND APPEARANCE
    CVS ORAL ANESTHETIC 
    benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-186
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    D&C YELLOW NO. 10  
    FD&C RED NO. 40  
    SPEARMINT OIL  
    PEPPERMINT OIL  
    METHYLPARABEN  
    POLYETHYLENE GLYCOL 400  
    PROPYLENE GLYCOL  
    SACCHARIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-186-51 1 in 1 CARTON
    1 30 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part356 07/08/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    Name Address ID/FEI Business Operations
    Pharma Pac, LLC 140807475 manufacture
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