Label: CAMPHO-PHENIQUE ANTISEPTIC (camphor- synthetic and phenol gel

  • NDC Code(s): 69536-109-50
  • Packager: Foundation Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 1, 2021

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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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