Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ca661c30-a5db-4c1a-8d5d-3e0a016558d1
Route
TOPICAL
Published
Effective Date 2011-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Isopropyl Myristate Propylene Glycol .alpha.-tocopherol Acetate, D- Aminomethylpropanol Carbomer 934

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-10-13

Description

ETHYL ALCOHOL 62%

Purpose

ANTIMICROBIAL


Medication Information

Purpose

ANTIMICROBIAL

Description

ETHYL ALCOHOL 62%

Uses

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

Warnings

FOR EXTERNAL USE ONLY. KEEP AWAY FROM FIRE.

Directions

PLACE ENOUGH PRODUCT IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS.  RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

STORE AT TEMPERATURE BELOW 1100C (430C)

Inactive Ingredients

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

Front and Back Labels

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 A Doctor If

IRRITATION OR RASH DEVELOPS AND LASTS.


Structured Label Content

Uses (USES)

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTIMICROBIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. KEEP AWAY FROM FIRE.

Directions (DIRECTIONS)

PLACE ENOUGH PRODUCT IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS.  RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

STORE AT TEMPERATURE BELOW 1100C (430C)

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Front and Back Labels (Front and back labels)

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 A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

IRRITATION OR RASH DEVELOPS AND LASTS.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)