NDC 58575-131 Dermagel Clear


NDC Product Code 58575-131

NDC 58575-131-01

Package Description: 1000 mL in 1 POUCH

NDC 58575-131-08

Package Description: 237 mL in 1 BOTTLE, PUMP

NDC 58575-131-18

Package Description: 532 mL in 1 BOTTLE, PUMP

NDC 58575-131-80

Package Description: 800 mL in 1 POUCH

NDC Product Information

Dermagel Clear with NDC 58575-131 is a a human over the counter drug product labeled by Inopak. Ltd. The generic name of Dermagel Clear is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Inopak. Ltd

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.

Dermagel Clear 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 70 mL/100mL

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.

Product Labeler Information

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

Labeler Name: Inopak. Ltd
Labeler Code: 58575
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: 05-03-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dermagel Clear 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


Drug Facts

Questions?Call: 1-800-762-7725 or visit our website: www.inopak.comNOT TESTED ON ANIMALSInopak, LTD.Ringwood, NJ 07456

Otc - Active Ingredient

Active IngredientEthyl Alcohol 70% v/v

Otc - Purpose


Indications & Usage

  • UsesTo decrease bacteria on the skin that potentially can cause disease.Recommended for repeated use.


  • WarningsFlammable, keep away from heat or flame.For external use only.

Otc - When Using

Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.

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. Children should be supervised by an adult when using this product.

Dosage & Administration

  • DirectionsApply sufficient amount of product to your palm to cover both hands.Rub until dry.

Storage And Handling

Other informationMay discolor certain fabrics and surfaces

Inactive Ingredient

Inactive ingredientsAcrylates/C10/30 Alkyl Acrylate Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

* Please review the disclaimer below.