Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e2061f15-7951-4ef8-aa66-62b9fe45e2fd
Route
TOPICAL
Published
Effective Date 2014-01-23
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 Aloe Vera Leaf .alpha.-tocopherol Acetate Octinoxate Avobenzone Octisalate Ppg-26-buteth-26 Polyoxyl 40 Hydrogenated Castor Oil Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-01-22

Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN

Section 51945-4

Warnings

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

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

STORE AT A ROOM TEMPERATURE BELOW 110°F (43°C)

Inactive Ingredients

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPERHYL ACETATE, ETHYHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, BLUE 1 (CI 42090), YELLOW 5 (CI 19140)

When Using This Product

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

Stop Use and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Keep Out of Reach of Children

IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY


Structured Label Content

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

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

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

STORE AT A ROOM TEMPERATURE BELOW 110°F (43°C)

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPERHYL ACETATE, ETHYHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, BLUE 1 (CI 42090), YELLOW 5 (CI 19140)

When Using This Product (WHEN USING THIS PRODUCT)

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

IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY


Advanced Ingredient Data


Raw Label Data

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