NDC 72901-001 Active Hydrogen Professional Gel

Menthol

NDC Product Code 72901-001

NDC Code: 72901-001

Proprietary Name: Active Hydrogen Professional Gel Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 72901 - 8.0 Ideal Balance D.o.o. Beograd
    • 72901-001 - Active Hydrogen Professional Gel

NDC 72901-001-01

Package Description: 100 mL in 1 TUBE

NDC Product Information

Active Hydrogen Professional Gel with NDC 72901-001 is a a human over the counter drug product labeled by 8.0 Ideal Balance D.o.o. Beograd. The generic name of Active Hydrogen Professional Gel is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: 8.0 Ideal Balance D.o.o. Beograd

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 Additional informationCallout TooltipWhat 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.


Active Hydrogen Professional Gel Active Ingredient(s)

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

  • MENTHOL 12 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • AQUA REGIA (UNII: X3TT5X989E)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • BORIC ACID (UNII: R57ZHV85D4)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • GLYCEROL (1-(12-HYDROXYSTEARATE)) (UNII: X84XWP4TOC)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: 8.0 Ideal Balance D.o.o. Beograd
Labeler Code: 72901
FDA Application Number: part348 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-13-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Active Hydrogen Professional Gel Product Label Images

Active Hydrogen Professional Gel 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

Warnings

  • For external use onlyWhen using this product • use only as directed • do not bandage or use with heating pad or medicated patch • avoid contact with eyes and mucous membranes • do not apply to open wounds or damaged, broken or irritated skin • a slight burning may occur upon application with disappearing effect in short period of time

Purpose

Topical analgesic

Uses

Reduces and stops the inflammatory process, eliminates pain, reduces swelling, speeds uprecovery process after injuries, neutralizes excretion of lactic acid in the muscles

Dosage And Administration

Adults and children over 12 years:• apply a thin layer to the target - the sore spot• massage into painful area until thoroughly absorbed into skin• repeat the process several (4 to 5) times • wipe over with wet hand to remove any sense of tension• repeat the process minimum 3 times per days Children 12 years or younger: ask a doctor

Stop Use And Ask Doctor If

• condition worsens• redness is present• irritation develops• symptoms persist for more then 7 days or clear up and occur again within a few days

Active Ingredient

Menthol 1.2 %

Inactive Ingredients

Aqua, Ascorbic Acid, Boric Acid, Carboxy Methyl Cellulose, Magnesium Oxide, Potassium Sorbate, Glycerol.

* Please review the disclaimer below.

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