drug facts

drug facts
SPL v1
SPL
SPL Set ID 291555e9-5cc9-4101-b6f8-4646f59fb94d
Route
topical
Published
Effective Date 2013-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (620 mg)
Inactive Ingredients
water propylene glycol carbomer 934 glycerin isopropyl myristate aminomethylpropanol .alpha.-tocopherol acetate lactose microcrystalline wax hydroxypropyl cellulose ferric oxide yellow fd&c blue no. 1 fd&c yellow no. 5 fd&c red no. 40

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-07-05

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62% V/V


Medication Information

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

Uses

TO DECREASE BACTERIA ON THE SKIN.

Purpose

ANTISEPTIC

Directions

WET HANDS THROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information

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

Description

ETHYL ALCOHOL 62% V/V

Label Copy

Active Ingredient

ETHYL ALCOHOL 62% V/V

Inactive Ingredients:

WATER (AQUA), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, FRAGRANCE, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, LACTOSE, MICROCRYSTALLINE WAX, HYDROXYPROPYLCELLULOSE, IRON OXIDES (CI 77492), BLUE 1 (CI 42090), YELLOW 5 (CI 19140), RED 40 (CI 16035).

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

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

Uses (USES)

TO DECREASE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)

WET HANDS THROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information (OTHER INFORMATION)

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

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62% V/V

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, FRAGRANCE, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, LACTOSE, MICROCRYSTALLINE WAX, HYDROXYPROPYLCELLULOSE, IRON OXIDES (CI 77492), BLUE 1 (CI 42090), YELLOW 5 (CI 19140), RED 40 (CI 16035).

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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