CAMPHO-PHENIQUE COLD SORE TREATMENT (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE LLC]

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CAMPHO-PHENIQUE COLD SORE TREATMENT (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE LLC]
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NDC 69536-108-23
Set ID 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6
Category HUMAN OTC DRUG LABEL
Packager Foundation Consumer Healthcare LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Camphorated phenol (camphor 10.8% and phenol 4.7%)

  • Purposes

    Pain reliever/antiseptic

  • Uses

    • for temporary relief of pain and itching associated with cold sores and fever blisters
    • first aid to help prevent infection
  • Warnings

    For external use only

    Do not use

    • over large areas of the body
    • with a bandage

    Ask a doctor before use if you have

    • a deep or puncture wound
    • animal bites
    • serious burns

    When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not induce vomiting before contacting medical help or a Poison Control Center.

  • Directions

    • adults and children 2 years of age and over:
      • clean the affected area
      • apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily
      • do not bandage
    • children under 2 years of age: ask a doctor
  • Other information

    • store at room temperature. Avoid excessive heat above 40°C (104°F).
    • close cap tightly after use
  • Inactive ingredients

    light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil

  • Questions or comments?

    1-855-602-2676 weekdays 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Foundation Consumer Healthcare, LLC.
    Pittsburgh, PA 15205

  • PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

    with
    aloe

    MAXIMUM STRENGTH

    MEDICATED
    CAMPHO
    PHENIQUE®

    COLD SORE
    TREATMENT GEL

    Fights cold sores with a powerful formula to:

    immediately relieve
    pain & itch

    dry
    cold sore

    moisturize
    surrounding area

    Helps prevent infection

    NET WT 0.23 OZ (6.5 g)

    PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CAMPHO-PHENIQUE   COLD SORE TREATMENT
    camphor (synthetic) and phenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10.8 g  in 100 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69536-108-231 in 1 CARTON08/01/2017
    16.5 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 FINALpart34808/01/2017
    Labeler - Foundation Consumer Healthcare LLC (079675882)
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