Cybercy Mayer /kang Du Qing
Poloxamer 188
Shenzhen Senton Science & Technology Co. Ltd
Human Otc Drug
NDC 68991-003Cybercy Mayer /kang Du Qing also known as Poloxamer 188 is a human otc drug labeled by 'Shenzhen Senton Science & Technology Co. Ltd'. National Drug Code (NDC) number for Cybercy Mayer /kang Du Qing is 68991-003. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Cybercy Mayer /kang Du Qing drug includes Poloxamer 188 - 2.7 g/100g . The currest status of Cybercy Mayer /kang Du Qing drug is Active.
Drug Information:
| Drug NDC: | 68991-003 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cybercy Mayer /kang Du Qing |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Poloxamer 188 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Shenzhen Senton Science & Technology Co. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POLOXAMER 188 - 2.7 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | VAGINAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 20 May, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Shenzhen Senton Science & Technology Co. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 6958511701272
|
| UPC stands for Universal Product Code. |
| UNII: | LQA7B6G8JG
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68991-003-10 | 10 TUBE in 1 PACKAGE (68991-003-10) / 3 g in 1 TUBE | 20 May, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purposes antimicrobial
Product Elements:
Cybercy mayer /kang du qing poloxamer 188 poloxamer 188 poloxamer 188 coix lacryma-jobi seed curcuma amada whole bitter almond peach kernel oil glycereth-8 esters borneol acacia catechu bark boswellia sacra whole commiphora myrrha whole dragon's blood lactarius indigo whole sulfur menthol pinellia ternata whole brucea javanica whole artemisia princeps leaf oil polygala tenuifolia root atractylodes lancea root salvia miltiorrhiza root rubia cordifolia root osthol sparganium stoloniferum whole gallic acid monohydrate pseudolarix amabilis bark sanguisorba officinalis root perilla frutescens leaf gentiana manshurica whole euphorbia amygdaloides chrysanthemin sophora flavescens root rheum officinale stem corydalis bungeana whole bletilla striata whole celosia cristata flower coptis chinensis root agrimonia pilosa whole podophyllum resin gellan gum (low acyl) lysozyme, chicken egg white lactic acid sodium diacetate citric acid acetate sodium polymetaphosphate rose oil jasminum sambac flower
Indications and Usage:
Uses for vaginal cleansing. kills germs.
Warnings:
Warnings: discontinue use if any burning, itching, or irritation of the vagina occurs during use. wash and douche with water. do not douche to prevent pregnancy. during pregnancy. do not use during breast feeding. do not use during period and 4 days after period ends. children under 12 years of age do not use the product. if swallowed, get medical help or contact a poison control center right away. for external use only. do not use in eyes.
When Using:
Directions: 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.
Dosage and Administration:
Dosage 1 tube every day before bedtime
Package Label Principal Display Panel:
Drug facts image description