NDC 51028-003 Chamosyn Paraben Free

Barrier Cream Ointment Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51028-003
Proprietary Name:
Chamosyn Paraben Free
Non-Proprietary Name: [1]
Barrier Cream
Substance Name: [2]
Menthol; Zinc Oxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Links Medical Products
    Labeler Code:
    51028
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    01-01-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)

    Product Packages

    NDC Code 51028-003-00

    Package Description: 144 PACKET in 1 BOX / 5 g in 1 PACKET

    NDC Code 51028-003-01

    Package Description: 113 g in 1 TUBE

    Product Details

    What is NDC 51028-003?

    The NDC code 51028-003 is assigned by the FDA to the product Chamosyn Paraben Free which is a human over the counter drug product labeled by Links Medical Products. The generic name of Chamosyn Paraben Free is barrier cream. The product's dosage form is ointment and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 51028-003-00 144 packet in 1 box / 5 g in 1 packet, 51028-003-01 113 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Chamosyn Paraben Free?

    Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with clean tissue or a clean soft cloth before application of this product.Children under 12 years of age: consult a doctor.Apply externally to the affected area as needed up to 6 times daily or after each incontinence episode or diaper change.

    What are Chamosyn Paraben Free Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • MENTHOL 4.5 mg/g - A monoterpene cyclohexanol produced from mint oils.
    • ZINC OXIDE 200 mg/g - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.

    Which are Chamosyn Paraben Free UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Chamosyn Paraben Free Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Chamosyn Paraben Free?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1998442 - menthol 0.1 % / zinc oxide 20 % Topical Ointment
    • RxCUI: 1998442 - menthol 0.001 MG/MG / zinc oxide 0.2 MG/MG Topical Ointment
    • RxCUI: 1998442 - Menthol 0.001 MG/MG / ZNO 0.2 MG/MG Topical Ointment

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".