Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ee9bb0e2-80f2-4c67-a31e-c8618355b2aa
Route
TOPICAL
Published
Effective Date 2012-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Carbomer Copolymer Type A Glycerin Isopropyl Myristate Aminomethylpropanol .alpha.-tocopherol Acetate Mannitol .alpha.-cellulose Hypromellose 2208 (100 Mpa.s) Chromic Oxide Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-19

Description

ETHYL ALCOHOL 62%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Uses

HELPS REDUCE BACTERIA ON THE SKIN

Warnings

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

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, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM), ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE,  MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), BLUE 1 (CI 42090), YELLOW 10 (CI 47005)

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 POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS.


Structured Label Content

Uses (USES)

HELPS REDUCE BACTERIA ON THE SKIN

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.

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, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM), ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE,  MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), BLUE 1 (CI 42090), YELLOW 10 (CI 47005)

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 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.


Advanced Ingredient Data


Raw Label Data

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