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

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

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

PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

with
aloe

MAXIMUM STRENGTH

MEDICATED
CAMPHO
PHENIQUE®

COLD SORE
TREATMENT GEL

Fights cold sores with a powerful formula to:

immediately relieve
pain & itch

dry
cold sore

moisturize
surrounding area

Helps prevent infection

NET WT 0.23 OZ (6.5 g)

PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
Aloe Vera Leaf (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	08/01/2017

Labeler - Foundation Consumer Healthcare LLC (079675882)

Campho-Phenique® Cold Sore Treatment