MADA 70% ALCOHOL- alcohol gel

Mada 70% Alcohol by

Drug Labeling and Warnings

Mada 70% Alcohol by is a Otc medication manufactured, distributed, or labeled by Mada Medical Products, Inc., Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Alcohol Denat. 72% v/v

PURPOSE

Purpose

Antibacterial Agent

INDICATIONS & USAGE

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

WARNINGS

Warnings

For external use only.

FLAMMABLE Keep away from heat or flame.

Avoid contact with eyes.

If eye contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop.

If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children.

If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION

Directions

Apply a small amount to palm.

Briefly rub, covering hands with product until dry.

INACTIVE INGREDIENT

Inactive ingredients

Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Carbomer, Triisopropanolamine

PRINCIPAL DISPLAY PANEL

PRODUCT CODE

705555

STORE BETWEEN

33 TO 110F

MADA GEL 70% ALCOHOL

QUANTITY AND SIZE

55 Gallon Drum

BATCH NUMBER

EXP:

MANUFACTURED FOR:

MADA MEDICAL

625 WASHINGTON AVE.

CARLSTADT. NJ 07072

MADE IN USA

Rev:01/18

INGREDIENTS AND APPEARANCE

MADA 70% ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11928-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11928-005-55	208 L in 1 DRUM; Type 0: Not a Combination Product	10/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/12/2017

Labeler - Mada Medical Products, Inc. (048411862)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(11928-005)