MADA - alcohol gel 
Mada Medical Products, Inc.

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

Active ingredient

Ethyl Alcohol 62% v/v

Purpose

Antibacterial Agent

Uses

For hand cleaning to decrease bacteria on skin.

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.

Directions

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

Briskly rub,covering hands with product until dry.

Inactive ingredients

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

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)

container label

MADA 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11928-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11928-004-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2004
Labeler - Mada Medical Products, Inc. (048411862)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(11928-004)

Revised: 11/2017
Document Id: bd5d58b9-eb45-4688-970f-17175b2b14e9
Set id: b6d9d394-f660-490c-b3b3-d9e04f368115
Version: 1
Effective Time: 20171101
 
Mada Medical Products, Inc.