drug facts

drug facts
SPL v1
SPL
SPL Set ID e57c4a50-9423-4a0a-8771-1b5a50d28fce
Route
topical
Published
Effective Date 2012-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 mL)
Inactive Ingredients
water propylene glycol isopropyl myristate carbomer 934 glycerin aminomethylpropanol .alpha.-tocopherol acetate mannitol powdered cellulose hypromellose 2208 (4000 mpa.s) ferric oxide red d&c red no. 33 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-06-11
Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Medication Information

Warnings

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

Uses

TO DECREASE BACTERIA ON THE SKIN.

Purpose

ANTISEPTIC

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information

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

Description

ETHYL ALCOHOL 62%

Label Copy

Active Ingredient

ETHYL ALCOHOL 62%

Inactive Ingredients:

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, CARBOMER, GLYCERIN, FRAGRANCE (PARFUM), AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200), YELLOW 5 (CI 19140).

Questions Or Comments?

1-866-428-7327

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

Warnings (WARNINGS)

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

Uses (USES)

TO DECREASE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information (OTHER INFORMATION)

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

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, CARBOMER, GLYCERIN, FRAGRANCE (PARFUM), AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200), YELLOW 5 (CI 19140).

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-866-428-7327

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: 2026-02-15T11:55:29.137343 · Updated: 2026-03-14T22:53:10.919261