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  4. NDC Product Code: 83176-008 Dr. Luke Molluscum Wart Remover

NDC 83176-008 Dr. Luke Molluscum Wart Remover

Molluscum Wart Remover Liquid Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83176-008?
  4. Dr. Luke Molluscum Wart Remover Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
83176-008
Proprietary Name:
Dr. Luke Molluscum Wart Remover
Non-Proprietary Name: [1]
Molluscum Wart Remover
Substance Name: [2]
Chlorhexidine; Salicylic Acid
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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]
    Dr.luke Healthcare Llc
    Labeler Code:
    83176
    Product Label ID:
    f99dd6bb-ff18-a50d-e053-6294a90ae53c
    FDA Application Number: [6]
    M028
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    04-17-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 83176-008?

    The NDC code 83176-008 is assigned by the FDA to the product Dr. Luke Molluscum Wart Remover which is a human over the counter drug product labeled by Dr.luke Healthcare Llc. The generic name of Dr. Luke Molluscum Wart Remover is molluscum wart remover. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 83176-008-01 15 ml in 1 bottle . 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 Dr. Luke Molluscum Wart Remover?

    1. Wash wart and surrounding skin with rubbing alcohol orastringent solution (e.g.: Potassium Permanganate solution), anddry the area thoroughly. 2. Apply a small amount of liquid solution onto the wart with acotton swab, and press the wart 2-3 times. Avoid applying onhealthy skin. 3. Do not apply the liquid over 1 ml onto the affected area. Afterapplying, let the affected area dry. 4. Use once in the morning and evening continuously for 7 daysThe wart will begin to fall off after the last day of treatment. stopusing, and observe for 3 days.Repeat the treatment p rocess if the wart has not yet fallen off.lf swallowed,rinse immediately with water, and get medicalhelp or contact a poison control center right away

    What are Dr. Luke Molluscum Wart Remover 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.
    • CHLORHEXIDINE 1 mg/100mL - A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.
    • SALICYLIC ACID 1 mg/100mL - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.

    Which are Dr. Luke Molluscum Wart Remover UNII Codes?

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

    Which are Dr. Luke Molluscum Wart Remover 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:

    Which are the Pharmacologic Classes for Dr. Luke Molluscum Wart Remover?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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    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.

    [6] 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.

    [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".