Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8e992180-ca87-4aba-9689-82263561b392
Route
TOPICAL
Published
Effective Date 2017-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (77.75 mg) Phenol (10.8 mg)
Inactive Ingredients
Light Mineral Oil Silicon Dioxide Glycerin Eucalyptus Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-31

Description

Camphor (10.8%), Phenol (4.7%)

Purpose

Pain reliever/antiseptic


Medication Information

Purpose

Pain reliever/antiseptic

Description

Camphor (10.8%), Phenol (4.7%)

Uses

For the 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 or 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 near the eye. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Directions

Adults and children 2 years or over: clean the affected area. Apply directly to the cold sore or fever blister 1 to 3 times daily. Do not bandage. Children under 2 years: ask a doctor.

Active Ingredient

Camphor (10.8%), Phenol (4.7%)

Inactive Ingredients

Eucalyptus, Glycerin, Mineral Oil, Silica.

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.

Package/label Principal Display Panel

Structured Label Content

Uses

For the temporary relief of pain and itching associated with cold sores and fever blisters. First aid to help prevent infection.

Purpose

Pain reliever/antiseptic

Warnings

For external use only. Do not use over large areas of the body or 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 near the eye. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Directions

Adults and children 2 years or over: clean the affected area. Apply directly to the cold sore or fever blister 1 to 3 times daily. Do not bandage. Children under 2 years: ask a doctor.

Active Ingredient (Active ingredient)

Camphor (10.8%), Phenol (4.7%)

Inactive Ingredients

Eucalyptus, Glycerin, Mineral Oil, Silica.

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)