MADA MEDICAL FOAM SANITIZER- benzethonium chloride liquid 
Mada Medical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Benzethonium chloride 0.2 %

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

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.

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

Foaming Instant Hand Sanitizer Bag Label

Mada Medical Foaming IHS label

MADA MEDICAL  FOAM SANITIZER
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11928-682
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride0.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11928-682-411000 mL in 1 BAG
2NDC:11928-682-1750 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/02/2010
Labeler - Mada Medical (048411862)
Registrant - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture

Revised: 7/2011
Document Id: a3baee18-524b-47f7-a8c3-f904793cbba5
Set id: 0c43232c-33fe-4fca-856e-ee22a4d47aa8
Version: 1
Effective Time: 20110712
 
Mada Medical