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SPL v1

SPL

SPL Set ID 0e491a7a-4204-439f-862d-741cbc0be9fd

Route

TOPICAL

Published

Effective Date 2023-11-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (6 g)

Inactive Ingredients

Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-15

Description

DRUG FACTS

Purpose

Topical Analgesic

Medication Information

Warnings and Precautions

Warnings

Purpose

Topical Analgesic

Description

DRUG FACTS

Uses:

For temporary relief of pain and itching associated with minor burns ,scrapes and insect bites.

Section 42229-5

DRUG FACTS

Section 50570-1

For external use only.

Flammable .Keep away from fire or flame.

Do not use in the eyes. If contact occurs ,flush eyes with water.

Section 51727-6

Isopropyl Alcohol, Purified Water

Section 51945-4

Directions

Apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older. Children under 2 years : consult physician.

Other Information: Store at room temperature.

Active Ingredient

Benzocaine ..........................6%

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses:

For temporary relief of pain and itching associated with minor burns ,scrapes and insect bites.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

For external use only.

Flammable .Keep away from fire or flame.

Do not use in the eyes. If contact occurs ,flush eyes with water.

Section 51727-6 (51727-6)

Isopropyl Alcohol, Purified Water

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Directions

Apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older. Children under 2 years : consult physician.

Other Information: Store at room temperature.

Active Ingredient

Benzocaine ..........................6%

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "Isopropyl Alcohol", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "For temporary relief of pain and itching associated with minor burns ,scrapes and insect bites.", "34071-1": "Warnings", "42229-5": "DRUG FACTS", "50570-1": "For external use only. Flammable .Keep away from fire or flame. Do not use in the eyes. If contact occurs ,flush eyes with water.", "51727-6": "Isopropyl Alcohol, Purified Water", "Purpose": "Topical Analgesic", "Directions": "Apply to affected area not more than 3 to 4 times daily, for adults and children 2 years of age or older. Children under 2 years : consult physician. Other Information: Store at room temperature.", "Active Ingredient": "Benzocaine ..........................6% ", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.756373 · Updated: 2026-03-14T23:01:49.492831