Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3e9cf8af-75fe-40b8-bff2-58d9d9c28edf
Route
TOPICAL
Published
Effective Date 2011-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Propylene Glycol Glycerin Isopropyl Myristate .alpha.-tocopherol Acetate, D- Aminomethylpropanol Shea Butter Mannitol Powdered Cellulose Hypromelloses Carbomer 934 Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-01-31

Description

ETHYL ALCOHOL 62%

Purpose

ANTIMICROBIAL


Medication Information

Purpose

ANTIMICROBIAL

Description

ETHYL ALCOHOL 62%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY-HANDS.

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

Directions

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

Active Ingredient

ETHYL ALCOHOL 62%

Other Information
STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT (43 DEGREES CELCIUS).
Inactive Ingredients

WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, BUTYROSPERMUM PARKII (SHEA BUTTER), MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CARBOMER, FRAGRANCE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492).

When Using This Product
AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

Stop Using and Ask A Doctor

IF IRRITATION OR RASH APPEARS 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

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTIMICROBIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY-HANDS.

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

Directions (DIRECTIONS)

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

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)
STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT (43 DEGREES CELCIUS).
Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, BUTYROSPERMUM PARKII (SHEA BUTTER), MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CARBOMER, FRAGRANCE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492).

When Using This Product (WHEN USING THIS PRODUCT)
AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

Stop Using and Ask A Doctor (STOP USING AND ASK A DOCTOR)

IF IRRITATION OR RASH APPEARS 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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