drug facts

drug facts
SPL v1
SPL
SPL Set ID 5a2f4da2-ecfb-4a5a-b051-6b1189804ef4
Route
topical
Published
Effective Date 2015-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water carbomer 934 propylene glycol isopropyl alcohol glycerin aminomethylpropanol sulisobenzone trideceth-9 hydrogenated castor oil fd&c red no. 40 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-01-21

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 110°F (43°C)

Inactive Ingredients

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, GLYCERIN, AMINOMETHYL PROPANOL, BENZOPHENONE-4, TRIDECETH-9, HYDROGENATED CASTOR OIL, RED 40 (CI 16035), YELLOW 5 (CI 19140)

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)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, GLYCERIN, AMINOMETHYL PROPANOL, BENZOPHENONE-4, TRIDECETH-9, HYDROGENATED CASTOR OIL, RED 40 (CI 16035), YELLOW 5 (CI 19140)

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

All Sections (JSON)