Label: CARMEX MULTI-SYMPTOM 3 IN 1 COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT- benzocaine, white petrolatum cream

  • NDC Code(s): 10210-0048-1
  • 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%

    White Petrolatum 44.69%

    Purpose

    External Analgesic

    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” anesthetic

    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

    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

    Using clean, dry hands apply 1 to 2 small dollops of Carmex Cold Sore product to the tip of the finger and gently apply and spread evenly to the surface of the cold sore to ensure even coverage over areas of redness. Wash hands thoroughly after application.

     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 age Should 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 sunlight • Store between 0° C to 28° C (32° F to 82.4° F)

  • Inactive Ingredients:

    Polyethylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Titanium Dioxide, Behenyl Olivate, PPG-51 SMDI Copolymer, Mica, Synthetic Wax, Calcium Silicate, Flavor, Isopropyl Titanium Triisostearate, Silica, Tin Oxide, Iron Oxides (C.I 77491, C.I 77492, C.I. 77499)

  • Package Labeling:

    Label4Label5

  • INGREDIENTS AND APPEARANCE
    CARMEX MULTI-SYMPTOM 3 IN 1 COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT 
    benzocaine, white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0048
    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 PETROLATUM446.9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BEHENYL OLIVATE (UNII: NGS1GGK4GW)  
    PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA)  
    MICA (UNII: V8A1AW0880)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0048-11 in 1 BLISTER PACK07/01/2020
    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 DrugM01707/01/2020
    Labeler - Carma Laboratories, Inc. (006090153)
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