drug facts

drug facts
SPL v1
SPL
SPL Set ID f30a18a7-5133-477a-9155-4ae1a4d0e253
Route
topical
Published
Effective Date 2013-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water carbomer 934 glycerin isopropyl alcohol propylene glycol mannitol powdered cellulose hypromelloses .alpha.-tocopherol acetate sulisobenzone aminomethylpropanol ferric oxide red d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-07-05

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%


Medication Information

Warnings

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

Uses

TO DECREASE BACTERIA ON THE SKIN.

Purpose

ANTISEPTIC

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information

STORE AT A TEMPERATURE BELOW 110F (43C).

Description

ETHYL ALCOHOL 65%

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Inactive Ingredients:

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, TOCOPHERYL ACETATE, BENZOPHENONE-4, AMINOMETHYL PROPANOL, IRON OXIDES (CI 77491), RED 33 (CI 17200). 

When Using This Product

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

Stop Use 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 IMMEDIATELY.


Structured Label Content

Warnings (WARNINGS)

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

Uses (USES)

TO DECREASE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110F (43C).

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), FRAGRANCE (PARFUM), CARBOMER, GLYCERIN, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, TOCOPHERYL ACETATE, BENZOPHENONE-4, AMINOMETHYL PROPANOL, IRON OXIDES (CI 77491), RED 33 (CI 17200). 

When Using This Product (WHEN USING THIS PRODUCT)

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

Stop Use and Ask A Doctor If (STOP USE 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 IMMEDIATELY.


Advanced Ingredient Data


Raw Label Data

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