Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ac5bd4b4-c25a-4394-89be-0ff4547044e5
Route
TOPICAL
Published
Effective Date 2014-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (620 mg)
Inactive Ingredients
Water Propylene Glycol Carbomer 934 Glycerin Sulisobenzone Mannitol Powdered Cellulose Hypromelloses .alpha.-tocopherol Acetate Isopropyl Myristate Aminomethylpropanol Fd&c Blue No. 1 Fd&c Yellow No. 5 Ferric Oxide Red Fd&c Red No. 4 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-11-16

Description

ETHYL ALCOHOL 62%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Uses

TO DECREASE BACTERIA ON THE SKIN

Warnings

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

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

Label Copy

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

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

Inactive Ingredients

WATER (AQUA), PROPYLENE GLYCOL, CARBOMER, FRAGRANCE (PARFUM), GLYCERIN, BENZOPHENONE-4, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, TOCOPHERYL ACETATE, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, IRON OXIDES (CI 77491), RED 4 (CI 14700), BLUE 1 (CI 42090), YELLOW 5 (CI 19140), RED 33 (CI 17200)

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 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)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), PROPYLENE GLYCOL, CARBOMER, FRAGRANCE (PARFUM), GLYCERIN, BENZOPHENONE-4, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, TOCOPHERYL ACETATE, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, IRON OXIDES (CI 77491), RED 4 (CI 14700), BLUE 1 (CI 42090), YELLOW 5 (CI 19140), RED 33 (CI 17200)

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

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