drug facts

drug facts
SPL v2
SPL
SPL Set ID a2a5b344-1431-40e7-a703-a94b56047a64
Route
topical
Published
Effective Date 2011-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (65 mL)
Inactive Ingredients
water isopropyl alcohol glycerin carbomer 934 aminomethylpropanol propylene glycol isopropyl myristate alpha-tocopherol acetate aloe vera leaf fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2011-06-01

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%


Medication Information

Warnings

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

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose

ANTISEPTIC

Directions

WET HANDS THROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information

STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT (43 DEGREES CELSIUS).

Inactive Ingredients

WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Description

ETHYL ALCOHOL 65%

Section 51945-4

Active Ingredient

ETHYL ALCOHOL 65%

Questions and Comments

1-866-695-3030

When Using This Product

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


Structured Label Content

Warnings (WARNINGS)

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

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)

WET HANDS THROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT (43 DEGREES CELSIUS).

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Questions and Comments (QUESTIONS AND COMMENTS)

1-866-695-3030

When Using This Product (WHEN USING THIS PRODUCT)

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


Advanced Ingredient Data


Raw Label Data

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