Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2d85d2c7-bd1c-413a-86ee-61a378508aeb
Route
TOPICAL
Published
Effective Date 2014-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Carbomer 934 Glycerin Isopropyl Alcohol Propylene Glycol Mannitol Powdered Cellulose Hypromelloses Sulibenzone Aminomethylpropanol .alpha.-tocopherol Acetate Chromium Hydroxide Green Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-20

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 SOURCE OF HEAT OR FIRE

Directions

APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HADNS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OLD SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

STORE AT A TEMPERATURE BELOW 110°F (43ºC)

Inactive Ingredients

WATER, FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, BENZOPHENONE-4, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, 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

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 DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

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

Directions (DIRECTIONS)

APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HADNS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OLD SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110°F (43ºC)

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, BENZOPHENONE-4, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, 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

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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