NDC 53152-2004 Alpha One


NDC Product Information

Alpha One with NDC 53152-2004 is a a human over the counter drug product labeled by Aoss Medical Supply, Inc.. The generic name of Alpha One is povidone-iodine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Aoss Medical Supply, 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.

Alpha One 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.


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)

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.
  • 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: Aoss Medical Supply, Inc.
Labeler Code: 53152
FDA Application Number: part333A 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: 10-24-2019 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: 12-31-2020 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.

Alpha One Product Label Images

Alpha One 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 Ingredients:
Povidone-iodine USP 10% w/v

Otc - Purpose


Indications & Usage

  • UsesHealth care antiseptic for preparation of the skin prior to surgeryFirst aid antiseptic to help reducce bacteria that potentially can cause skin infectionFor hospital and professional use


  • Warnings For external use only.Do not use:in the eyes.on individuals who are allergic or sensitive to iodineas a first aid antiseptic longer than 1 week unless directed by a doctor.

Otc - Ask Doctor

  • Ask a doctor before use if you havedeep or puncture wounds, animal bites or serious burns.

Otc - Stop Use

  • Stop use and ask a doctor ifirritation or redness develop

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsFor preparation of the skin prior to surgeryapply to the operative site prior to surgeryAs a first aid antisepticclean the affected areaapply a small amount of this product to the area 1-3 times dailymay be covered with a sterile bandageif bandaged, let dry first

Inactive Ingredient

Inactive IngredientsDisodium hydrogen phosphate, Glycerin, Hydroxyethyl cellulose, Purified water

Other Safety Information

Other InformationStore at room temperature.

* Please review the disclaimer below.