Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ba508625-8633-4dc4-b8ed-e8b17fb6dc78
Route
TOPICAL
Published
Effective Date 2013-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Propylene Glycol Carbomer 934 Glycerin Aminomethylpropanol .alpha.-tocopherol Acetate Isopropyl Myristate Aloe Vera Leaf Mannitol Powdered Cellulose Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide D&c Red No. 33 Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-09-12

Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAMES.

Directions

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

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

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

Questions/comments?

1-866-695-3030

Inactive Ingredients:

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, AMINOMETHY PROPANOL, TOCOPHERYL ACETATE, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), RED 33 (CI 17200), YELLOW 5 (CI 19140), BLUE 1 (CI 42090).

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS.


Structured Label Content

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAMES.

Directions (DIRECTIONS)

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

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

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

Questions/comments? (QUESTIONS/COMMENTS?)

1-866-695-3030

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, AMINOMETHY PROPANOL, TOCOPHERYL ACETATE, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), RED 33 (CI 17200), YELLOW 5 (CI 19140), BLUE 1 (CI 42090).

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

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.

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS.


Advanced Ingredient Data


Raw Label Data

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