Label: CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC- benzocaine cream

  • Category: HUMAN OTC DRUG LABEL

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Updated October 21, 2019

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  • CARMEX COLD SORE treatment External Analgesic

  • Active Ingredient

    Benzocaine 10%

  • Purpose

    External Analgesic / Anti-Itch

  • Uses

    • For the temporary relief of symptoms of cold sores and fever blisters
  • Warnings

    • For external use only
    • 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 keep out of eyes. Rinse with water to remove.
    • Do not exceed recommended dosage.
    • Stop use and ask a doctor or dentist if
      • cold sore symptoms do not improve in 7 days
      • irritation, pain, or redness persists or worsens
      • swelling, rash, or fever develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area (lips) not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Inactive Ingredients

    cyclomethicone, polyethylene glycol 600, dimethicone, silica, petrolatum, phenyl trimethicone, PEG/PPG-19/19 dimethicone, mica, peg 12 dimethicone, titanium dioxide, polyurethane-40, menthol, tin oxide

  • CARMEX COLD SORE treatment External Analgesic 2g (10210-0012-0)

    InnerLabel

    OuterLabel

  • INGREDIENTS AND APPEARANCE
    CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MENTHOL (UNII: L7T10EIP3A)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0012-02 g in 1 TUBE; Type 0: Not a Combination Product05/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/28/2014
    Labeler - Carma Laboratories, Inc. (006090153)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carma Laboratories, Inc.006090153manufacture(10210-0012)
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