Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 985a1d46-c1b4-4996-81b0-7a5a2eb02759
Route
TOPICAL
Published
Effective Date 2012-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65.0 mL)
Inactive Ingredients
Water Propylene Glycol Isopropyl Myristate Carbomer 934 Glycerin Aminomethylpropanol Aloe Vera Leaf Alpha-tocopherol Acetate Mannitol Alpha Cellulose Hypromellose 2910 (15000 Mpa.s) Chromic Oxide D&c Blue No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

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

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 SOURCES OF HEAT OR FIRE.

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

DO NOT STORE ABOVE 110F (43C).

Questions/comments?

1-866-578-4395

Inactive Ingredients:

WATER (AQUA), FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

When Using This Product

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

Stop Using 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 SOURCES OF HEAT OR FIRE.

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

DO NOT STORE ABOVE 110F (43C).

Questions/comments? (QUESTIONS/COMMENTS?)

1-866-578-4395

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), 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 Using and Ask A Doctor (STOP USING 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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