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NDC 11928-0006-55 MADA 70% ALCOHOL 72 L/100L Details

MADA 70% ALCOHOL 72 L/100L

MADA 70% ALCOHOL is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Mada Medical Products, Inc.. The primary component is ALCOHOL.

Product Information

NDC	11928-0006
Product ID	11928-006_b57ef0ef-809c-760a-e053-2995a90a88d2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MADA 70% ALCOHOL
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	72
Active Ingredient Units	L/100L
Substance Name	ALCOHOL
Labeler Name	Mada Medical Products, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 11928-0006-55 (11928000655)

Pricing Information	N/A
NDC Package Code	11928-006-55
Billing NDC	11928000655
Package	208 L in 1 DRUM (11928-006-55)
Marketing Start Date	2020-12-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b57ef0ef-809b-760a-e053-2995a90a88d2 Details

Active Ingredient

Ethyl alcohol 72% v/v

Purpose

Antiseptic

USE

Hand sanitizer to help decrease bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eye thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

If hands are visibly soiled, wash with soap and water then dry hands.
Wet hands thoroughly with product, especially under the fingernails and allow to dry without rinsing.
Children under 6 years of age should be supervised when using this product.

Other Information

Store below 110F (43C)
May discolor certain fabrics or surfaces

Unactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Aloe Barbadensis Leaf Juice.

PRINCIPAL DISPLAY PANEL

PRODUCT CODE

705555

STORE BETWEEN 33 TO 110F

MADA GEL 70% ALCOHOL

QUANTITY AND SIZE:

55 GALLON DRUM

MANUFACTURED FOR:

MADA MEDICAL PRODUCTS, INC.

625 WASHINGTON AVENUE

CARLSTADT, NEW JERSEY 07072

MADE IN USA

LOT NUMBER:

EXP:

Rev:12/20

INGREDIENTS AND APPEARANCE

MADA 70% ALCOHOL

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11928-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11928-006-55	208 L in 1 DRUM; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)	12/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/02/2020

Labeler - Mada Medical Products, Inc. (048411862)

Name	Address	ID/FEI	Business Operations
Establishment
Diamond Chemical Co Inc		001381482	manufacture(11928-006)

Revised: 12/2020

Document Id: b57ef0ef-809c-760a-e053-2995a90a88d2

Set id: b57ef0ef-809b-760a-e053-2995a90a88d2

Version: 1

Effective Time: 20201202