Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6bf0e5a9-6000-474b-aab0-8b2f0c79c870
Route
TOPICAL
Published
Effective Date 2015-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (620 mg)
Inactive Ingredients
Water Propylene Glycol Glycerin Isopropyl Myristate Aminomethylpropanol Carbomer 934 .alpha.-tocopherol Acetate Jasminum Officinale Flower Green Tea Leaf Ocimum Basilicum Flowering Top Aloe Vera Leaf Mannitol Powdered Cellulose Hypromelloses Chromium Hydroxide Green Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-01-15

Description

ETHYL ALCOHOL 62%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 62%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN

Warnings
  • FOR EXTERNAL USE ONLY
  • FLAMMABLE
  • KEEP AWAY FROM SOURCE OF HEAT OR FIRE
Directions
  • APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY
  • CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT
Label Copy

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

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

Inactive Ingredients

WATER (AQUA), PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE (PARFUM), JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, OCIMUM BASILICUM (BASIL) FLOWER/LEAF, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), BLUE 1 (CI 42090)

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE 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

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)
  • FOR EXTERNAL USE ONLY
  • FLAMMABLE
  • KEEP AWAY FROM SOURCE OF HEAT OR FIRE
Directions (DIRECTIONS)
  • APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY
  • CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT
Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE (PARFUM), JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, OCIMUM BASILICUM (BASIL) FLOWER/LEAF, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CHROMIUM HYDROXIDE GREEN (CI 77289), YELLOW 5 (CI 19140), BLUE 1 (CI 42090)

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE 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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