Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 254dca83-5d69-4a35-8052-074f370eb8f7
Route
TOPICAL
Published
Effective Date 2013-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mg)
Inactive Ingredients
Water Isopropyl Alcohol Ethylhexylglycerin Propylene Glycol Isopropyl Myristate .alpha.-tocopherol Acetate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aminomethylpropanol D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-12

Description

ETHYL ALCOHOL 70% V/V

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 70% V/V

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Warnings

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

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY. CHILDREN UNDER 12 SHOULD BE SUPERVISED BY AN ADULT.

Label Copy

Active Ingredient

ETHYL ALCOHOL 70% V/V

Other Information

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

Inactive Ingredients:

WATER (AQUA), ISOPROPYL ALCOHOL, ETHYLHEXYLGLYCERIN, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), EXT. VIOLET 2 (CI 60730).

Questions Or Comments?

1-800-842-7886

When Using This Product

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

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. (1-800-222-1222).

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 HEAT OR FIRE SOURCE.

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY. CHILDREN UNDER 12 SHOULD BE SUPERVISED BY AN ADULT.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 70% V/V

Other Information (OTHER INFORMATION)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), ISOPROPYL ALCOHOL, ETHYLHEXYLGLYCERIN, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), EXT. VIOLET 2 (CI 60730).

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-842-7886

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY 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. (1-800-222-1222).

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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