Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 67d18f83-eb96-42ae-90f4-883f3bca0b77

Route

TOPICAL

Published

Effective Date 2015-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzocaine (2.00 mg)

Inactive Ingredients

Light Mineral Oil Docosanol Benzyl Alcohol Sucrose Stearate Propylene Glycol Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2015-04-01

Description

Benzocaine

Purpose

Cold Sore/Fever Blister Treatment/Pain Reliever

Medication Information

Purpose

Cold Sore/Fever Blister Treatment/Pain Reliever

Description

Benzocaine

Uses

For treatment of cold sores/fever blisters on the face and lips

Warnings

For external use only: Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butocaine, benzocaine, or other “caine: anesthetics.

Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.

When using this product avoid contact with eyes. Use only as directed.

Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.

Directions

Clean the affected

Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily

Children under 2 years of age: consult a physician

Rub in gently – Applies clear

Wash hands before and after applying cream

Do not share this product with anyone

Active Ingredient

Benzocaine

Inactive Ingredients

Benzyl Alcohol, Docosanol, Mineral Oil, Propylene Glycol, Sucrose Stearate, Tocopherol, Water.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Package/label Principal Display Panel

Structured Label Content

Uses

For treatment of cold sores/fever blisters on the face and lips

Purpose

Cold Sore/Fever Blister Treatment/Pain Reliever

Warnings

For external use only: Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butocaine, benzocaine, or other “caine: anesthetics.

Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.

When using this product avoid contact with eyes. Use only as directed.

Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.

Directions

Clean the affected

Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily

Children under 2 years of age: consult a physician

Rub in gently – Applies clear

Wash hands before and after applying cream

Do not share this product with anyone

Active Ingredient (Active ingredient)

Benzocaine

Inactive Ingredients

Benzyl Alcohol, Docosanol, Mineral Oil, Propylene Glycol, Sucrose Stearate, Tocopherol, Water.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

Advanced Ingredient Data

[{"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "2.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "5.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "DOCOSANOL", "unii": "9G1OE216XY", "classCode": "IACT", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "9.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SUCROSE STEARATE", "unii": "274KW0O50M", "classCode": "IACT", "strengthNumerator": "5.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "4.99", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "64", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For treatment of cold sores/fever blisters on the face and lips", "Purpose": "Cold Sore/Fever Blister Treatment/Pain Reliever", "Warnings": "For external use only: Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butocaine, benzocaine, or other “caine: anesthetics. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician. When using this product avoid contact with eyes. Use only as directed. Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.", "Directions": "Clean the affected Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily Children under 2 years of age: consult a physician Rub in gently – Applies clear Wash hands before and after applying cream Do not share this product with anyone", "Active ingredient": "Benzocaine", "Inactive Ingredients": "Benzyl Alcohol, Docosanol, Mineral Oil, Propylene Glycol, Sucrose Stearate, Tocopherol, Water.", "Keep Out of Reach of Children": "If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:55.569681 · Updated: 2026-03-14T22:53:59.046955