Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3344a72a-ab94-444c-ad1f-ae8d97a12cc1
Route
TOPICAL
Published
Effective Date 2011-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Carbomer 934 Aminomethylpropanol Propanediol Isopropyl Myristate Aloe Vera Leaf Tocopherol Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-12-13

Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY. SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT.

Label Copy



Active Ingredient

ETHYL ALCOHOL 65%

Other Information

STORE BELOW 110 F (43 C)

Inactive Ingredients

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Questions / Comments

1-888-723-3929

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES 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 and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS


Structured Label Content

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY. SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT.

Label Copy (LABEL COPY)



Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

STORE BELOW 110 F (43 C)

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Questions / Comments (QUESTIONS / COMMENTS)

1-888-723-3929

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES 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 and Ask A Doctor If (STOP USING AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS


Advanced Ingredient Data


Raw Label Data

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