NDC 11928-005 Mada 70% Alcohol

Alcohol

NDC Product Code 11928-005

NDC 11928-005-55

Package Description: 208 L in 1 DRUM

NDC Product Information

Mada 70% Alcohol with NDC 11928-005 is a a human over the counter drug product labeled by Mada Medical Products, Inc.. The generic name of Mada 70% Alcohol is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Mada Medical Products, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Mada 70% Alcohol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 72 L/100L

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mada Medical Products, Inc.
Labeler Code: 11928
FDA Application Number: part333E What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-12-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Mada 70% Alcohol Product Label Images

Mada 70% Alcohol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredientAlcohol Denat. 72% v/v

Otc - Purpose

PurposeAntibacterial Agent

Indications & Usage

UsesHand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

WarningsFor external use only.FLAMMABLE Keep away from heat or flame.

Otc - When Using

Avoid contact with eyes. If eye contact occurs, flush with water.

Otc - Stop Use

Stop use if, in rare instances, redness or irritation develop.If condition persists for more than 72 hours, consult a physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, contact a physician or poison control center.

Dosage & Administration

DirectionsApply a small amount to palm.Briefly rub, covering hands with product until dry.

Inactive Ingredient

Inactive ingredientsWater, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Carbomer, Triisopropanolamine

* Please review the disclaimer below.