CAMPHO-PHENIQUE ANTISEPTIC (CAMPHOR (SYNTHETIC) AND PHENOL) LIQUID [FOUNDATION CONSUMER HEALTHCARE LLC]

CAMPHO-PHENIQUE ANTISEPTIC (CAMPHOR (SYNTHETIC) AND PHENOL) LIQUID [FOUNDATION CONSUMER HEALTHCARE LLC]
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NDC 69536-110-75
Set ID 82edaef0-0709-4ae1-a664-c9c5adb91ee1
Category HUMAN OTC DRUG LABEL
Packager Foundation Consumer Healthcare LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • 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
      • insect bites
      • minor burns
      • sunburn
      • minor cuts
      • scrapes
      • cold sores
    • first aid to help protect against infection in
      • minor cuts
      • scrapes
      • burns
  • 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 on the area 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, aloe barbadensis leaf extract, 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 - 22 mL Bottle Carton

    with
    aloe

    MAXIMUM
    STRENGTH

    MEDICATED
    CAMPHO
    PHENIQUE®

    PAIN & ITCH
    RELIEF
    ANTISEPTIC LIQUID

    Multi-purpose formula

    insect
    bites

    minor
    burns

    cuts, scrapes
    & irritations

    Helps prevent infection

    3/4 FL OZ (22 mL)

    Principal Display Panel - 22 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CAMPHO-PHENIQUE   ANTISEPTIC
    camphor (synthetic) and phenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10.8 mg  in 100 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4.7 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69536-110-751 in 1 CARTON11/15/2021
    122 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/01/2017
    Labeler - Foundation Consumer Healthcare LLC (079675882)

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