Label: CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT- benzocaine, white petrolatum cream

  • NDC Code(s): 10210-0027-1
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • Drug Facts

  • Active Ingredients

    Benzocaine 10.0%

    White Petrolatum 45.9%

    Purpose

    External Analgesic / Anti-Itch

    Skin Protectant

  • Uses

    • For temporary relief of pain and itching associated with symptoms of fever blisters and cold sores
    • Helps prevent and protect dry, chapped lips
  • 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

    Stop use and ask a doctor if

    • cold sore symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, or fever develops

    Do not use on

    • deep or puncture wounds • animal bites • serious burns

    When using this product

    keep out of eyes. Rinse with water to remove. Do not exceed recommended dosage.

    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 2-12 years of ageShould be supervised in use of this product
    Children under 2 years of age Ask a doctor

  • Other Information

    • Protect this product from excessive heat and direct sun
    • Store between 0°C to 28°C (32°F to 82.4°F)
  • Inactive Ingredients

    polyethylene glycol, HDI/trimethylol hexyllactone crosspolymer, mica, behenyl olivate, PPG-51 SMDI copolymer, titanium dioxide, synthetic wax, calcium silicate, silica, flavor, iron oxides (C.I. 77491), isopropyl titanium triisostearate

  • Package Labeling:

    BottlePack

  • INGREDIENTS AND APPEARANCE
    CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT 
    benzocaine, white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (BENZOCAINE - UNII:U3RSY48JW5) WHITE PETROLATUM459 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    MICA (UNII: V8A1AW0880)  
    BEHENYL OLIVATE (UNII: NGS1GGK4GW)  
    PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0027-11 in 1 BLISTER PACK03/02/2017
    12 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/02/2017
    Labeler - Carma Laboratories, Inc. (006090153)
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