Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 74cbc16e-59a2-4358-95cf-55914d873077
Route
TOPICAL
Published
Effective Date 2012-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Propylene Glycol Carbomer 934 Glycerin Isopropyl Myristate Alpha-tocopherol Acetate Aminomethylpropanol Mannitol Powdered Cellulose Hypromellose 2208 (4000 Mpa.s) Ferric Oxide Red D&c Red No. 33 Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-06-26

Description

ETHYL ALCOHOL 62%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Warnings

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

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Label Copy

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

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

Inactive Ingredients:

WATER (AQUA), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, FRAGRANCE (PARFUM), ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE,  IRON OXIDES (CI 77491), RED 33 (CI 17200), EXT. VIOLET 2 (CI 60730).

Questions Or Comments?

1-877-932-7948

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 FOR MORE THAN 7 DAYS.


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 HEAT SOURCE.

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), PROPYLENE GLYCOL, CARBOMER, GLYCERIN, FRAGRANCE (PARFUM), ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE,  IRON OXIDES (CI 77491), RED 33 (CI 17200), EXT. VIOLET 2 (CI 60730).

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-877-932-7948

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 FOR MORE THAN 7 DAYS.


Advanced Ingredient Data


Raw Label Data

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