CAMPHO-PHENIQUE COLD SORE TREATMENT (camphor- synthetic and phenol gel

Campho-Phenique by

Drug Labeling and Warnings

Campho-Phenique by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

colloidal silicon dioxide, eucalyptus oil, glycerin, light mineral 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

MAXIMUM STRENGTH

MEDICATED
Campho-
Phenique®

Cold Sore Treatment

• Instantly relieves
  pain & itch

NET WT 0.23 OZ (6.5 g)

INGREDIENTS AND APPEARANCE

CAMPHO-PHENIQUE   COLD SORE TREATMENT
camphor (synthetic) and phenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10.8 g  in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-108-23	1 in 1 CARTON	08/01/2017
1		6.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	08/01/2017

Labeler - Foundation Consumer Healthcare LLC (079675882)