NDC 68991-002 Mayer /kang Du Qing Cybercy

Poloxamer 188 Gel Vaginal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
68991-002
Proprietary Name:
Mayer /kang Du Qing Cybercy
Non-Proprietary Name: [1]
Poloxamer 188
Substance Name: [2]
Poloxamer 188
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Vaginal - Administration into the vagina.
  • Labeler Code:
    68991
    FDA Application Number: [6]
    M003
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    05-20-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 68991-002?

    The NDC code 68991-002 is assigned by the FDA to the product Mayer /kang Du Qing Cybercy which is a human over the counter drug product labeled by Shenzhen Senton Science & Technology Co. Ltd. The generic name of Mayer /kang Du Qing Cybercy is poloxamer 188. The product's dosage form is gel and is administered via vaginal form. The product is distributed in a single package with assigned NDC code 68991-002-10 10 tube in 1 package / 3 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 Mayer /kang Du Qing Cybercy?

    Insert the gel into the vagina when cleansing is desired, one tube each time before bed.Please read the following instructions carefully before use.1. Take off the package from bottom. Take out the applicator with caution and protect the small plastic tip from falling off the applicator.2. Remove the the front cap and treat it as holder of the applicator.3. Lie down and slowly insert the applicator into the vagina. When discomfort or resistance occurs, stops the applicator to prevent from injury. And gently release the gel for one time only.4. Remove the applicator slowly and keep lying down for 15 minutes.5. Discard it in a waste container.Do not use this product if the package seal is broken.CAUTION:Persons with skin allergy use with caution.

    What are Mayer /kang Du Qing Cybercy 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.
    • POLOXAMER 188 2.7 g/100g - A nonionic polyoxyethylene-polyoxypropylene block co-polymer with the general formula HO(C2H4O)a(-C3H6O)b(C2H4O)aH. It is available in different grades which vary from liquids to solids. It is used as an emulsifying agent, solubilizing agent, surfactant, and wetting agent for antibiotics. Poloxamer is also used in ointment and suppository bases and as a tablet binder or coater. (Martindale The Extra Pharmacopoeia, 31st ed)

    * 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.

    [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".