Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 884631aa-f940-458f-a187-537eab5ed59d
Route
TOPICAL
Published
Effective Date 2012-09-28
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 .alpha.-tocopherol Acetate Ascorbyl Palmitate Chromium Hydroxide Green Fd&c Red No. 4 D&c Red No. 33 Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-09-27

Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

TO DECREASE BACTERIA ON THE SKIN.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

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

Inactive Ingredients:

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

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 DECREASE BACTERIA ON THE SKIN.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

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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