Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 82005398-857f-417d-b046-6f6d049b6e65
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

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Uses

TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY-HANDS.

FLAMMABLE.  KEEP AWAY FROM HEAT AND FLAME.

Directions

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING.  FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.  NOT RECOMMENDED FOR INFANTS.

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

DO NOT STORE ABOVE 105 DEGREES FAHRENHEIT.  MAY DISCOLOR SOME FABRICS, HARMFUL TO WOOD FINISHES AND PLASTICS.

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

KEEP OUT OF EYES.  IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

Stop Use and Ask A Doctor

IF SKIN IRRITATION DEVELOPS.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.


Structured Label Content

Uses (USES)

TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY-HANDS.

FLAMMABLE.  KEEP AWAY FROM HEAT AND FLAME.

Directions (DIRECTIONS)

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING.  FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.  NOT RECOMMENDED FOR INFANTS.

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

DO NOT STORE ABOVE 105 DEGREES FAHRENHEIT.  MAY DISCOLOR SOME FABRICS, HARMFUL TO WOOD FINISHES AND PLASTICS.

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)

KEEP OUT OF EYES.  IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

Stop Use and Ask A Doctor (STOP USE AND ASK A DOCTOR)

IF SKIN IRRITATION DEVELOPS.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.


Advanced Ingredient Data


Raw Label Data

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