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

Purpose

Pain reliever/antiseptic

Description

Camphor (10.8%), Phenol (4.7%)


Medication Information

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.

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

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.

Inactive Ingredients

Eucalyptus, Glycerin, Mineral Oil, Silica.

Description

Camphor (10.8%), Phenol (4.7%)

Active Ingredient

Camphor (10.8%), Phenol (4.7%)

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

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.

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

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.

Inactive Ingredients

Eucalyptus, Glycerin, Mineral Oil, Silica.

Active Ingredient (Active ingredient)

Camphor (10.8%), Phenol (4.7%)

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

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