Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 95ab6fcb-c3f5-42e9-a769-1c445da865e2
Route
TOPICAL
Published
Effective Date 2013-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mg)
Inactive Ingredients
Water Isopropyl Alcohol Ethylhexylglycerin Glycerin Isopropyl Myristate Propylene Glycol .alpha.-tocopherol Acetate Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-12-26

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), ISOPROPYL ALCOHOL, ETHYLHEXYLGLYCERIN, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM)

Questions Or Comments?

1-888-423-0139

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 DEVELOP AND LAST

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), ISOPROPYL ALCOHOL, ETHYLHEXYLGLYCERIN, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-888-423-0139

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 DEVELOP AND LAST

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

All Sections (JSON)