Label: CVS PHARMACY MOUTH SORE GEL- benzocaine, benzalkonium chloride and zinc chloride gel, dentifrice 

  • Label RSS
  • NDC Code(s): 59779-913-92, 59779-913-99
  • Packager: CVS Pharmacy
  • 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 11/12

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

  • Active ingredients

    Benzalkonium Chloride 0.02% .............................................................. Oral Antiseptic

    Benzocaine 20.0% (w/w) ..................................................................... Oral Pain Reliever

    Zonc Chloride 0.1% .............................................................................. Oral Astringent

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  • Uses

    temporary relieves pain caused by canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and
    gums

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  • 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

    • 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, swelling, rash or fever develops, irritation, pain or redness persists or worsens

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

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  • Directions

    • cut open tip of tube on scoremark

    • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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.
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  • Other Information

    Store in a cool dry place. Keep tube capped when not in use.

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  • Inactive ingredients

    allantoin, carbomer, edetate disodium, mentha piperita, polyethylene glycol, polysorbate 60, propylene glycol, propyl gallate, water, PVP, sodium saccharin, sorbic acid, stearyl alcohol

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  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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.

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  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

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  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  MOUTH SORE GEL
    benzocaine gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-913
    Route of Administration Oral DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 20.00 g  in 100 g
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.02 g  in 100 g
    ZINC CHLORIDE (ZINC CATION) ZINC CHLORIDE 0.1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 60  
    WATER  
    SACCHARIN SODIUM  
    EDETATE DISODIUM  
    SORBIC ACID  
    STEARYL ALCOHOL  
    POVIDONE K90  
    CARBOMER HOMOPOLYMER TYPE B  
    PROPYLENE GLYCOL  
    ALLANTOIN  
    PROPYL GALLATE  
    Product Characteristics
    Color white (White clear to slight pink orange) Score     
    Shape Size
    Flavor PEPPERMINT (mentha piperota) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-913-99 1 in 1 CARTON
    1 NDC:59779-913-92 11.9 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 10/01/2012
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(59779-913), pack(59779-913)
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