CVS ORAL ANESTHETIC (BENZOCAINE) LIQUID [CVS PHARMACY]

CVS ORAL ANESTHETIC (BENZOCAINE) LIQUID [CVS PHARMACY]
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NDC 59779-186-51
Set ID d033dfab-66d1-4538-abcc-f09658ef7f49
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART356
  • 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


    c


  • 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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