Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5ee89a4a-d0de-4a4e-a804-fc0717648c2b
Route
TOPICAL
Published
Effective Date 2013-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-02-14

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

WET HANDS THOROUGHLY AND RUN TOGETHER UNTIL DRY.

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

STORE AT A TEMPERTAURE BELOW 110F (43C)

Inactive Ingredients:

WATER (AQUA), CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), ISOPROPYL ALCOHOL, GLYCERIN, PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), BLUE 1 (CI 42090), 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)

WET HANDS THOROUGHLY AND RUN TOGETHER UNTIL DRY.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

STORE AT A TEMPERTAURE BELOW 110F (43C)

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), ISOPROPYL ALCOHOL, GLYCERIN, PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), BLUE 1 (CI 42090), 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

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