MADA MEDICAL FOAM SANITIZER- benzethonium chloride liquid

Mada Medical by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Benzethonium chloride 0.2 %

PURPOSE

Hand sanitizer to help reduce bacteria on the skin that could cause disease.  Recommended for repeated use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center.

To decrease bacteria on skin, apply small amount of product to palms.  Briskly rub, covering hands with product until dry.

For external use only.  Avoid contact with eyes.  If contact occurs, flush with water.

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply small amount to palm.  Briskly rub, covering hands with product until dry.  Children should be supervised when using product.

Water, Fragrance, Aloe Barbadensis, Tocopheryl Acetate, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Propylene Glycol, Phenoxyethanol, Tetrasodium EDTA

PRINCIPAL DISPLAY PANEL

Foaming Instant Hand Sanitizer Bag Label

INGREDIENTS AND APPEARANCE

MADA MEDICAL  FOAM SANITIZER
benzethonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11928-682
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP)	Benzethonium Chloride	0.2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Edetate Sodium (UNII: MP1J8420LU)
Propylene Glycol (UNII: 6DC9Q167V3)
Phenoxyethanol (UNII: HIE492ZZ3T)
Aloe Vera Flower (UNII: 575DY8C1ER)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
Glyceryl Cocoate (UNII: WVK1CT5994)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11928-682-41	1000 mL in 1 BAG
2	NDC: 11928-682-17	50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/02/2010

Labeler - Mada Medical (048411862)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture