drug facts

drug facts
SPL v1
SPL
SPL Set ID a0f07fe2-63e7-4908-ac4f-7c25d396738b
Route
topical
Published
Effective Date 2013-07-29
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 final active Since 2013-03-15

Purpose

External Analgesic

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 puncture wound, animal bites, or serious burns.

When using this product: avoid contact with eyes. Rinse with water to remove. Seek medical help or contact a Poison Control Center.

Stop use and consult a doctor if: conditions worsen or last more than 7 days, or if it clears up and returns again in a few days.

Uses

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

Purpose

External Analgesic

Directions

Adults and children over 2 years clean the affected area and apply directly to a cold sore or fever blister 1 to 3 times daily. Do not bandage.

Inactive Ingredients

Colloidal Silicon Dioxide, Eucalyptus Oil, Glycerin, Light Mineral Oil

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 immediately. Do not induce vomiting before contacting medical help or a Poison Control Center. For adults and children over 2 years of age.

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 puncture wound, animal bites, or serious burns.

When using this product: avoid contact with eyes. Rinse with water to remove. Seek medical help or contact a Poison Control Center.

Stop use and consult a doctor if: conditions worsen or last more than 7 days, or if it clears up and returns again in a few days.

Uses

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

Purpose

External Analgesic

Directions

Adults and children over 2 years clean the affected area and apply directly to a cold sore or fever blister 1 to 3 times daily. Do not bandage.

Inactive Ingredients

Colloidal Silicon Dioxide, Eucalyptus Oil, Glycerin, Light Mineral Oil

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 immediately. Do not induce vomiting before contacting medical help or a Poison Control Center. For adults and children over 2 years of age.

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

Advanced Ingredient Data


Raw Label Data

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