Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 82df10f3-5a82-4503-871a-13054cb531f2
Route
TOPICAL
Published
Effective Date 2011-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Aluminum Oxide Isopropyl Myristate Titanium Dioxide Sheanut Oil .alpha.-tocopherol Acetate, D- Carbomer 934 Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-02-03

Description

ETHYL ALCOHOL 62%

Purpose

ANTIBACTERIAL


Medication Information

Purpose

ANTIBACTERIAL

Description

ETHYL ALCOHOL 62%

Uses:

TO DECREASE BACTERIA ON THE SKIN.

Section 50565-1

FOR CHILDREN UNDER 6, USE ONLY WITH ADULT SUPERVISION. NOT RECOMMENDED FOR USE ON INFANTS.

Section 51945-4

Warnings

FOR EXTERNAL USE ON THE HANDS ONLY.  IN CASE OF ACCIDENTAL INGESTION, SEEK MEDICAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions:

PUT A SMALL AMOUNT IN YOUR PALM AND BRISKLY RUB HANDS TOGETHER UNTIL DRY.

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

FLAMMABLE.  KEEP AWAY FROM HEAT AND FLAME.

Inactive Ingredients

WATER, GLYCERIN, ALUMINA, ISOPROPYL MYRISTATE,  TITANIUM DIOXIDE, BUTYROSPERMUM PARKII (SHEA BUTTER) EXRACT, TOCOPHERYL ACETATE, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE.

When Using This Product

AVOID CONTACT WITH EYES.  IF EYE CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

If Skin Irritation Develops,

DISCONTINUE USE AND CONTACT A DOCTOR.


Structured Label Content

Uses: (USES:)

TO DECREASE BACTERIA ON THE SKIN.

Section 50565-1 (50565-1)

FOR CHILDREN UNDER 6, USE ONLY WITH ADULT SUPERVISION. NOT RECOMMENDED FOR USE ON INFANTS.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTIBACTERIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ON THE HANDS ONLY.  IN CASE OF ACCIDENTAL INGESTION, SEEK MEDICAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions: (DIRECTIONS:)

PUT A SMALL AMOUNT IN YOUR PALM AND BRISKLY RUB HANDS TOGETHER UNTIL DRY.

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

FLAMMABLE.  KEEP AWAY FROM HEAT AND FLAME.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, GLYCERIN, ALUMINA, ISOPROPYL MYRISTATE,  TITANIUM DIOXIDE, BUTYROSPERMUM PARKII (SHEA BUTTER) EXRACT, TOCOPHERYL ACETATE, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE.

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES.  IF EYE CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

If Skin Irritation Develops, (IF SKIN IRRITATION DEVELOPS,)

DISCONTINUE USE AND CONTACT A DOCTOR.


Advanced Ingredient Data


Raw Label Data

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