Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID addb4377-e876-47cf-a080-30d8dd3ab7e2
Route
TOPICAL
Published
Effective Date 2013-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mg)
Inactive Ingredients
Water Propylene Glycol Isopropyl Alcohol Ethylhexylglycerin Glycerin Isopropyl Myristate .alpha.-tocopherol Acetate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aloe Vera Leaf Aminomethylpropanol Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-09-19

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 SOURCE OF HEAT OR FIRE.

Directions

PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY. CHILDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Label Copy

Active Ingredient

ETHYL ALCOHOL 70% V/V

Other Information

STORE AT A TEMPERATURE BELOW 110°F (43°C). MAY DISCOLOR SOME FABRICS OR SURFACES.

Inactive Ingredients:

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, ETHYLHEXYLGLYCERIN, GLYCERIN, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Questions Or Comments?

1-800-289-8343

When Using This Product

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

Stop Use and Ask A Doctor If

IRRITATION OR REDNESS DEVELPS AND LASTS.

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 HELP REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

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

Directions (DIRECTIONS)

PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY. CHILDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 70% V/V

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110°F (43°C). MAY DISCOLOR SOME FABRICS OR SURFACES.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, ETHYLHEXYLGLYCERIN, GLYCERIN, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-289-8343

When Using This Product (WHEN USING THIS PRODUCT)

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

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELPS AND LASTS.

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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