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

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 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.

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 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 (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.

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