CVS PHARMACY MOUTH SORE GEL (BENZOCAINE) GEL, DENTIFRICE [CVS PHARMACY]

CVS PHARMACY MOUTH SORE GEL (BENZOCAINE) GEL, DENTIFRICE [CVS PHARMACY]
PDF | XML

NDC 59779-913-92, 59779-913-99
Set ID 77f84651-7706-4042-acdd-dc68ba97771d
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART333B
  • Active ingredients

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

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

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

  • Uses

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

  • 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.

  • 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.
  • Other Information

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

  • Inactive ingredients

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

  • 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.

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  MOUTH SORE GEL
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-913
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.02 g  in 100 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    Product Characteristics
    Colorwhite (White clear to slight pink orange) Score    
    ShapeSize
    FlavorPEPPERMINT (mentha piperota) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-913-991 in 1 CARTON01/07/2013
    1NDC:59779-913-9211.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/01/201202/19/2023
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(59779-913) , pack(59779-913)

Related Drugs