SPL v7
SPL
SPL Set ID 6e905065-10a9-1ded-e053-2a91aa0a46a1
Route
TOPICAL
Published
Effective Date 2018-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (6 g) Alcohol (60 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-14
Description

Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic

Purpose

Topical Anesthetic Antiseptic

Medication Information

Purpose



Topical Anesthetic



Antiseptic

Description

Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic

Uses

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

Section 44425-7

Flammable - keep away from fire or flame.

Section 50570-1

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

Warnings

Warnings: For external use only.

Avoid contact with eyes. If this happens, rinse thoroughly with water.

Directions

Clean intended area thoroughly with pad. Discard after single use.

Package Labeling

Active Ingredient

Active Ingredient: Purpose:

Benzocaine, 6% w/v.................. Topical Anesthetic

SD alcohol, 60% w/v.................. Antiseptic

Inactive Ingredients

Purified water

Keep Out of Reach of Children

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

Structured Label Content

Uses

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

Section 44425-7 (44425-7)

Flammable - keep away from fire or flame.

Section 50570-1 (50570-1)

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

Purpose



Topical Anesthetic



Antiseptic

Warnings

Warnings: For external use only.

Avoid contact with eyes. If this happens, rinse thoroughly with water.

Directions

Clean intended area thoroughly with pad. Discard after single use.

Package Labeling (Package labeling)

Active Ingredient

Active Ingredient: Purpose:

Benzocaine, 6% w/v.................. Topical Anesthetic

SD alcohol, 60% w/v.................. Antiseptic

Inactive Ingredients

Purified water

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:45.784264 · Updated: 2026-03-14T23:13:10.446567