NDC 72901-001 Active Hydrogen Professional Gel

NDC Product Code 72901-001

NDC CODE: 72901-001

Proprietary Name: Active Hydrogen Professional Gel What 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.

NDC Code Structure

  • 72901 - 8.0 Ideal Balance D.o.o. Beograd

NDC 72901-001-01

Package Description: 100 mL in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Active Hydrogen Professional Gel with NDC 72901-001 is a product labeled by 8.0 Ideal Balance D.o.o. Beograd. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2045038.

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.

  • 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)

Product Labeler Information

What 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
Start Marketing Date: 03-13-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

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.