drug facts

drug facts
SPL v1
SPL
SPL Set ID 7872096e-7faa-4d4c-97d3-a11b93b5d849
Route
topical
Published
Effective Date 2013-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water carbomer 934 aminomethylpropanol isopropyl alcohol glycerin propylene glycol sulisobenzone mannitol powdered cellulose .alpha.-tocopherol acetate vitamin a palmitate hypromelloses chromium hydroxide green fd&c yellow no. 5 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-02-06

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%


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 THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information

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

Description

ETHYL ALCOHOL 65%

Section 51945-4

Active Ingredient

ETHYL ALCOHOL 65%

Inactive Ingredients:

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, GLYCERIN, PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, TOCOPHERYL ACETATE, RETINYL PALMITATE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), BLUE 1 (CI 42090).

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

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 THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information (OTHER INFORMATION)

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

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, GLYCERIN, PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, TOCOPHERYL ACETATE, RETINYL PALMITATE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), BLUE 1 (CI 42090).

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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