Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7d257c32-edcb-41ce-81bb-fd51ad2da7d1
Route
TOPICAL
Published
Effective Date 2011-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Isopropyl Myristate Propylene Glycol .alpha.-tocopherol Acetate, D- Vitamin A Palmitate Aminomethylpropanol Sulisobenzone Carbomer 934 Mannitol Powdered Cellulose Hypromelloses D&c Blue No. 4 Fd&c Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-03-21

Description

ETHYL ALCOHOL 62%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Section 51945-4

Warnings

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

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Active Ingredient

ETHYL ALCOHOL 62%

Inactive Ingredients

WATER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, RETINYL PALMITATE, AMINOMETHYL PROPANOL, BENZOPHENONE-4, CARBOMER, FRAGRANCE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 4 (CI 14700), YELLOW 5 (CI 19140).

Questions Or Comments

1-800-910-6874

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY 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 FOR MORE THAN 72 HOURS.


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 AWAY FROM FIRE OR FLAME.

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, RETINYL PALMITATE, AMINOMETHYL PROPANOL, BENZOPHENONE-4, CARBOMER, FRAGRANCE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 4 (CI 14700), YELLOW 5 (CI 19140).

Questions Or Comments (QUESTIONS OR COMMENTS)

1-800-910-6874

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY 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 FOR MORE THAN 72 HOURS.


Advanced Ingredient Data


Raw Label Data

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