73288-004

73288-004
SPL v6
SPL
SPL Set ID 0c901f64-6890-45c0-9ca7-ee9de87903c4
Route
TOPICAL
Published
Effective Date 2019-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (10 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-18
Description

Active Ingredient: Benzocaine 10% w/v

Medication Information

Warnings and Precautions

Warnings:

For external use only

Do not use: In the eyes, on broken skin, deep puncture wounds. I f unusal redness, swelling, irritation, or other symptoms occur, consult a physician immediately. 

Indications and Usage

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

Dosage and Administration

Directions: Wipe injection site vigorously and discard

Description

Active Ingredient: Benzocaine 10% w/v

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Flammable. Keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water.

Section 51727-6

Inactive Ingredient

Purified Water

Section 51945-4

Section 55105-1

Purpose: Topical Anesthetic

Section 55106-9

Active Ingredient: Benzocaine 10% w/v

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions: Wipe injection site vigorously and discard

Warnings and Precautions (34071-1)

Warnings:

For external use only

Do not use: In the eyes, on broken skin, deep puncture wounds. I f unusal redness, swelling, irritation, or other symptoms occur, consult a physician immediately. 

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Flammable. Keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredient

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Topical Anesthetic

Section 55106-9 (55106-9)

Active Ingredient: Benzocaine 10% w/v

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:10.784947 · Updated: 2026-03-14T23:12:20.443473