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

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

CAMPHO-PHENIQUE ANTISEPTIC (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE LLC]
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NDC 69536-109-50
Set ID 46b84e0b-78a9-4cde-9f90-e165b5419162
Category HUMAN OTC DRUG LABEL
Packager Foundation Consumer Healthcare
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
      • minor burns
      • sunburn
      • minor cuts
      • scrapes
      • insect bites
      • minor skin irritation
    • 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, 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

    Distributed by:
    Foundation Consumer Healthcare, LLC.
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

    with
    aloe

    MAXIMUM STRENGTH

    MEDICATED
    CAMPHO
    PHENIQUE®

    PAIN & ITCH RELIEF
    ANTISEPTIC GEL

    Multi-purpose formula

    insect bites | minor burns | cuts, scrapes & irritations

    Helps prevent infection

    NET WT 0.5 OZ (14 g)

    PRINCIPAL DISPLAY PANEL - 14 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CAMPHO-PHENIQUE  ANTISEPTIC
    camphor (synthetic) and phenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-109
    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:69536-109-501 in 1 CARTON11/15/2021
    114 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 finalpart34811/15/2021
    Labeler - Foundation Consumer Healthcare (079675882)
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