Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a2a5b344-1431-40e7-a703-a94b56047a64
Route
TOPICAL
Published
Effective Date 2011-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Carbomer 934 Aminomethylpropanol Propylene Glycol Isopropyl Myristate Alpha-tocopherol Acetate Aloe Vera Leaf Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-06-01

Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Section 51945-4

Warnings

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

Directions

WET HANDS THROUGHLY AND RUB TOGETHER UNTIL DRY.

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT (43 DEGREES CELSIUS).

Inactive Ingredients

WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Questions and Comments

1-866-695-3030

When Using This Product

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

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

Directions (DIRECTIONS)

WET HANDS THROUGHLY AND RUB TOGETHER UNTIL DRY.

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT (43 DEGREES CELSIUS).

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Questions and Comments (QUESTIONS AND COMMENTS)

1-866-695-3030

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE EYES 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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