Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7e5c4787-c835-4afd-8d07-d5941dd39a06
Route
TOPICAL
Published
Effective Date 2011-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Propylene Glycol Glycerin Isopropyl Myristate Alpha-tocopherol Acetate Niacinamide Vitamin A Palmitate Aminomethylpropanol Titanium Dioxide Carbomer Homopolymer Type C Sodium Pyrrolidone Carboxylate Sodium Lactate Arginine Aspartic Acid Glycine Alanine Serine Valine Proline Threonine Isoleucine Histidine Phenylalanine Mannitol Powdered Cellulose Hypromelloses Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-03-18

Description

ETHYL ALCOHOL 62%

Purpose

ANTIMICROBIAL


Medication Information

Purpose
ANTIMICROBIAL
Description

ETHYL ALCOHOL 62%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

Directions
APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT(43 DEGREES CELSIUS).

Inactive Ingredients

WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, NIACINAMIDE, RETINYL PALMITATE, AMINOMETHYL PROPANOL, TITANIUM DIOXIDE, CARBOMER, SODIUM PCA, SODIUM LACTATE, ARGININE, ASPARTIC ACID, PCA, GLYCINE, ALANINE, SERINE, VALINE, PROLINE, THREONINE, ISOLEUCINE, HISTIDINE, PHENYLALANINE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, FRAGRANCE, IRON OXIDE (CI 77491).

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 APPEARS AND LASTS.


Structured Label Content

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN.

Section 51945-4 (51945-4)

Purpose (PURPOSE)
ANTIMICROBIAL
Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

Directions (DIRECTIONS)
APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT(43 DEGREES CELSIUS).

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, NIACINAMIDE, RETINYL PALMITATE, AMINOMETHYL PROPANOL, TITANIUM DIOXIDE, CARBOMER, SODIUM PCA, SODIUM LACTATE, ARGININE, ASPARTIC ACID, PCA, GLYCINE, ALANINE, SERINE, VALINE, PROLINE, THREONINE, ISOLEUCINE, HISTIDINE, PHENYLALANINE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, FRAGRANCE, IRON OXIDE (CI 77491).

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 (STOP USING THIS PRODUCT AND ASK A DOCTOR)

IF IRRITATION OR RASH APPEARS AND LASTS.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)