Mada by Mada Medical Products, Inc. / Kutol Products Company MADA- alcohol gel

Mada by

Drug Labeling and Warnings

Mada 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

Ethyl Alcohol 62% v/v

PURPOSE

Purpose

Antibacterial Agent

INDICATIONS & USAGE

Uses

For hand cleaning to decrease bacteria on skin.

WARNINGS

Warnings

For external use only.

FLAMMABLE Keep away from heat or flame.

Do not use in eyes.

In case of contact, rinse thoroughly.

Stop use and ask a doctor if irritation and redness appears and lasts.

Keep out of reach of children.

If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION

Directions

To decrease bacteria on skin, apply a small amount to palm.

Briskly rub,covering hands with product until dry.

INACTIVE INGREDIENT

Inactive ingredients

Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol

PRINCIPAL DISPLAY PANEL

MadaGel

Instant

Hand Sanitizer

with

Moisturizers

Broad Spectrum

Antimicrobial Effectiveness

Kills 99.9% of

common bacteria

in seconds without

using water.

4 Fl. Oz. (118ml)

INGREDIENTS AND APPEARANCE

MADA 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11928-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62 mL  in 100 mL

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)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11928-004-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2004

Labeler - Mada Medical Products, Inc. (048411862)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(11928-004)