Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 23ca18ac-9232-4399-8dc5-6176cddd3e04
Route
TOPICAL
Published
Effective Date 2012-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Carbomer 934 Glycerin Isopropyl Myristate Aminomethylpropanol Alpha-tocopherol Acetate Mannitol Alpha Cellulose Hypromellose 2208 (4000 Mpa.s) Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-01

Description

ETHYL ALCOHOL 62%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Uses

HELPS REDUCE BACTERIA ON THE SKIN.

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Label Copy

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

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

Inactive Ingredients:

WATER (AQUA), PROPYLENE GLYCOL, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), CARAMEL.

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)

HELPS REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

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 110F (43C).

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), PROPYLENE GLYCOL, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), CARAMEL.

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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