drug facts

drug facts
SPL v1
SPL
SPL Set ID 707e0b41-4845-48e1-aac4-59ebb5a9a800
Route
topical
Published
Effective Date 2014-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water propylene glycol carbomer 934 glycerin aminomethylpropanol .alpha.-tocopherol acetate mannitol powdered cellulose hypromelloses isopropyl myristate chromium hydroxide green fd&c yellow no. 5 d&c red no. 33 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-08-14

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

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

Inactive Ingredients

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ISOPROPYL MYRISTATE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)

Description

ETHYL ALCOHOL 65%

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

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)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, ISOPROPYL MYRISTATE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), RED 33 (CI 17200), BLUE 1 (CI 42090)

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

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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