NDC 72901-002 Active Hydrogen Professional Cream

Menthol

NDC Product Code 72901-002

NDC Code: 72901-002

Proprietary Name: Active Hydrogen Professional Cream 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.

Non-Proprietary Name: Menthol What 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.

NDC Code Structure

  • 72901 - 8.0 Ideal Balance D.o.o. Beograd
    • 72901-002 - Active Hydrogen Professional Cream

NDC 72901-002-01

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Active Hydrogen Professional Cream with NDC 72901-002 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 Cream is menthol. The product's dosage form is cream and is administered via topical form.

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

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Active Hydrogen Professional Cream 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.

  • MENTHOL 70 mg/mL

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)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETEARETH-12 (UNII: 7V4MR24V5P)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BORIC ACID (UNII: R57ZHV85D4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: 8.0 Ideal Balance D.o.o. Beograd
Labeler Code: 72901
FDA Application Number: part348 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: 03-28-2019 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.

Active Hydrogen Professional Cream Product Label Images

Active Hydrogen Professional Cream 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

Directions

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 one again.• repeat the process minimum 3 times per day 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 7.0 %

Inactive Ingredients

Ascorbic Acid, Aqua, Boric Acid, Butylated Hydroxytoluene, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Ethylhexanoate, Disodium Edta, Glycerol, Glyceryl Stearate (and) Ceteareth-20 (and) Ceteareth-12 (and) Cetearyl Alcohol (and) Cetyl Palmitate, Magnesium Oxide, Paraffinum Liquidum, Perfume, Phenoxyethanol (and) Ethylhexylglycerin, Propylene Glycol, Tocopheryl Acetate.

* Please review the disclaimer below.

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