FDA Label for Campho-phenique Antiseptic

View Indications, Usage & Precautions

Campho-phenique Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Foundation Consumer Healthcare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

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


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

Otc - Ask Doctor



Ask a doctor before use if you have

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

Otc - When Using



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


Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



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



colloidal silicon dioxide, eucalyptus oil, glycerin, light mineral oil


Questions Or Comments?



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Principal Display Panel - 14 G Tube Carton



ORIGINAL FORMULA

MEDICATED
Campho-
Phenique
®

Pain & Itch Relief Antiseptic Gel

NET WT 0.5 OZ (14 g)


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