drug facts

drug facts

SPL v1

SPL

SPL Set ID 8b92923f-8dff-4736-b1fb-35ac03f82bcb

Route

topical

Published

Effective Date 2013-07-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

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

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 puncture wound, animal bites, or serious burns.

When using this product: do not use near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Stop use and consult a doctor if: conditions worsen or symptoms persist more than 7 days, or 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

Pain Reliever/Antiseptic

Directions

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. Children under 2 years: ask a doctor.

Inactive Ingredients

Eucalyptus Globulus Leaf Oil, 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 immediately. 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 puncture wound, animal bites, or serious burns.

When using this product: do not use near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Stop use and consult a doctor if: conditions worsen or symptoms persist more than 7 days, or 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

Pain Reliever/Antiseptic

Directions

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. Children under 2 years: ask a doctor.

Inactive Ingredients

Eucalyptus Globulus Leaf Oil, 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 immediately. 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

[{"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "77.75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "10.8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "5.75", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PHENOL", "unii": "339NCG44TV", "classCode": "ACTIB", "strengthNumerator": "4.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "0.500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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 puncture wound, animal bites, or serious burns. When using this product: do not use near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention. Stop use and consult a doctor if: conditions worsen or symptoms persist more than 7 days, or clears up and returns again in a few days.", "Directions": "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. Children under 2 years: ask a doctor.", "Active ingredient": "Camphor 10.8%, Phenol 4.7%", "Inactive Ingredients": "Eucalyptus Globulus Leaf Oil, Glycerin, Mineral Oil, Silica", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.564536 · Updated: 2026-03-14T22:53:33.698024