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

CVS PHARMACY MOUTH SORE (BENZOCAINE) GEL, DENTIFRICE [CVS PHARMACY]
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NDC 69842-358-98
Set ID 4f4dc81e-5d75-4837-92c7-9fe1465afcaf
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART356
  • ACTIVE INGREDIENT

    Active ingredients

    Benzalkonium Chloride 0.02%

    Benzocaine 20%

    Zinc Chloride 0.1%

  • PURPOSE

    Purpose

    Oral Antiseptic

    Oral Pain Reliever

    Oral Astringent

  • INDICATIONS & USAGE

    Uses

    temporarily relieves pain caused by

    • canker sores
    • cold sores
    • fever blisters
    • minor irritation or injury of the mouth and gums
    • to help against infection of minor oral irritation
  • 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

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • cut open tip of tube on scoremark
    • do not use if tip is cut prior to opening
    • adults and children 2 years of age and older: apply to affected area 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.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Allantoin, Carbomer, Edetate Disodium, Mentha Piperita (Peppermint) Oil, Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol

  • PRINCIPAL DISPLAY PANEL

    Carton label

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  MOUTH SORE
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-358
    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
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    Product Characteristics
    Colorwhite (White/clear to yellow to slight pink/orange) Score    
    ShapeSize
    FlavorPEPPERMINT (peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-358-981 in 1 CARTON11/01/2012
    111.9 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 finalpart35611/01/201212/17/2022
    Labeler - CVS Pharmacy (062312574)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(69842-358)

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