drug facts

drug facts
SPL v1
SPL
SPL Set ID 01e238b7-e9c4-4ad2-9dea-25086b0fcfe3
Route
topical
Published
Effective Date 2013-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water isopropyl alcohol glycerin carbomer 934 aminomethylpropanol propylene glycol sulisobenzone mannitol powdered cellulose hypromelloses chromium hydroxide green fd&c red no. 4 d&c red no. 33 caramel

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-10-27

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

Other Information

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

Inactive Ingredients

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), RED 4 (CI 14700), RED 33 (CI 17200), CARAMEL

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

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), RED 4 (CI 14700), RED 33 (CI 17200), CARAMEL

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)