OTC Medication Information: Mada

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.

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
(click image for full-size original)
MADA
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11928-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
ISOPROPYL MYRISTATE
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
CARBOXYPOLYMETHYLENE
AMINOMETHYLPROPANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11928-004-04 118 mL in 1 BOTTLE, PLASTIC None
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 Operations
Kutol Products Company 004236139 manufacture (11928-004)

Revised: 11/2017 Mada Medical Products, Inc.

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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