drug facts

drug facts
SPL v1
SPL
SPL Set ID 496d7cec-272e-40c7-8af5-05a708ff38c0
Route
topical
Published
Effective Date 2013-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water isopropyl alcohol glycerin carbomer 934 aminomethylpropanol propylene glycol isopropyl myristate .alpha.-tocopherol acetate, d-

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-05-28

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%


Medication Information

Active Ingredient

ETHYL ALCOHOL 65%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose

ANTISEPTIC

Dosage and Administration

APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Other Information

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

Inactive Ingredients

WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.

Description

ETHYL ALCOHOL 65%

Label Copy

Questions and Comments

1-866-322-2439

When Using This Product

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

Stop Using and Ask A Doctor

IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Structured Label Content

Active Ingredient (55106-9)

ETHYL ALCOHOL 65%

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Dosage and Administration (34068-7)

APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.

Label Copy (LABEL COPY)

Questions and Comments (QUESTIONS AND COMMENTS)

1-866-322-2439

When Using This Product (WHEN USING THIS PRODUCT)

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

Stop Using and Ask A Doctor (STOP USING AND ASK A DOCTOR)

IF IRRITATION OR REDNESS DEVELOPS 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 RIGHT AWAY.


Advanced Ingredient Data


Raw Label Data

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