Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 151f4944-cfeb-45aa-b27f-7450c5348164
Route
TOPICAL
Published
Effective Date 2013-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Carbomer 934 Glycerin Isopropyl Alcohol Propylene Glycol Mannitol Powdered Cellulose Hypromelloses Sulisobenzone Aminomethylpropanol Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide D&c Orange No. 4 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-27
Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC

Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE

Directions

APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OLD SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

STORE AT A TEMPERATURE BELOW 110°F (43°C)

Inactive Ingredients

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, BENZOPHENONE-4, AMINOMETHYL PROPANOL, IRON OXIDE (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), ORANGE 4 (CI 15510), RED 40 (CI 16035)

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER

Stop Use and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Structured Label Content

Uses (USES)

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE

Directions (DIRECTIONS)

APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OLD SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110°F (43°C)

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, BENZOPHENONE-4, AMINOMETHYL PROPANOL, IRON OXIDE (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), ORANGE 4 (CI 15510), RED 40 (CI 16035)

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:42.559469 · Updated: 2026-03-14T22:53:36.648209