OTC Medication Information: Mada Medical Foam Sanitizer

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.

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
(click image for full-size original)
MADA MEDICAL FOAM SANITIZER
benzethonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11928-682
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzethonium Chloride (Benzethonium) Benzethonium Chloride 0.2 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Cocamidopropyl Betaine
Edetate Sodium
Propylene Glycol
Phenoxyethanol
Aloe Vera Flower
.ALPHA.-TOCOPHEROL ACETATE, D-
Glyceryl Cocoate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11928-682-41 1000 mL in 1 BAG None
2 NDC:11928-682-17 50 mL in 1 BOTTLE, PUMP None
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 Operations
Kutol Products Company, Inc. 004236139 manufacture

Revised: 07/2011 Mada Medical

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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