Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c94b7a03-949e-460c-88dc-f11d27b889e9
Route
TOPICAL
Published
Effective Date 2015-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Propylene Glycol Isopropyl Alcohol Carbomer 934 Aminomethylpropanol Sulisobenzone Glycerin Mannitol Powdered Cellulose Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-06-23
Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC

Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

 TO DECREASE BACTERIA ON THE SKIN

Warnings

FOR EXTERNAL USE ONLY

  • FLAMMABLE.
  • KEEP AWAY FROM SOURCE OF HEAT OR FIRE
Directions
  • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY
  • CHILDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT
Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Inactive Ingredients

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, CARBOMER, AMINOMETHYL PROPANOL, BENZOPHENONE-4, GLYCERIN, FRAGRANCE (PARFUM), MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491, CI 77492, CI 77499), BLUE 1(CI 42090), RED 40 (CI 16035), YELLOW 5 (CI 19140)

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)

 TO DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

  • FLAMMABLE.
  • KEEP AWAY FROM SOURCE OF HEAT OR FIRE
Directions (DIRECTIONS)
  • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY
  • CHILDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT
Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, CARBOMER, AMINOMETHYL PROPANOL, BENZOPHENONE-4, GLYCERIN, FRAGRANCE (PARFUM), MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491, CI 77492, CI 77499), BLUE 1(CI 42090), RED 40 (CI 16035), YELLOW 5 (CI 19140)

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

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Source: dailymed · Ingested: 2026-02-15T11:55:57.435955 · Updated: 2026-03-14T22:54:02.195419