drug facts

drug facts
SPL v1
SPL
SPL Set ID 5a080d91-8b49-4e76-8eac-95ddde0660e5
Route
topical
Published
Effective Date 2013-03-19
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 .alpha.-tocopherol acetate carbomer copolymer type a (allyl pentaerythritol crosslinked) aminomethylpropanol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-03-18

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 70% (V/V)


Medication Information

Warnings

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

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose

ANTISEPTIC

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

Other Information

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

Inactive Ingredients

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

Description

ETHYL ALCOHOL 70% (V/V)

Label Copy

Active Ingredient

ETHYL ALCOHOL 70% (V/V)

Questions Or Comments?

1-866-695-3030

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY 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. FLAMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

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

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 70% (V/V)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-866-695-3030

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY 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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