Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d0ef52a5-312f-4d26-9137-7d2dc45ab4c2
Route
TOPICAL
Published
Effective Date 2014-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Propylene Glycol Carbomer 934 Glycerin Aminomethylpropanol Mannitol Powdered Cellulose Hypromelloses Isopropyl Myristate .alpha.-tocopherol Acetate Aloe Vera Leaf Medium-chain Triglycerides Green Tea Leaf Vanilla Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Fd&c Yellow No. 5 D&c Red No. 33 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-02
Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC

Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN

Warnings

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

Directions

APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 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)

Questions/comments?

1-866-695-3030

Inactive Ingredients

WATER (AQUA), FRAGRANCE (PARFUM), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAMELLIA SINENSIS LEAF EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)

When Using This Product

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

Keep Out of Reach of Children

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

Stop Using This Product and Ask Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Structured Label Content

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

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

Directions (DIRECTIONS)

APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 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)

Questions/comments? (QUESTIONS/COMMENTS?)

1-866-695-3030

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), FRAGRANCE (PARFUM), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAMELLIA SINENSIS LEAF EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)

When Using This Product (WHEN USING THIS PRODUCT)

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

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

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:45.763414 · Updated: 2026-03-14T22:53:42.713163