Utimi Water Based Personal Lubricant
Personal Lubricant
Shenzhen Guangdian Technology Co., Ltd
Human Otc Drug
NDC 82624-101Utimi Water Based Personal Lubricant also known as Personal Lubricant is a human otc drug labeled by 'Shenzhen Guangdian Technology Co., Ltd'. National Drug Code (NDC) number for Utimi Water Based Personal Lubricant is 82624-101. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Utimi Water Based Personal Lubricant drug includes Hydroxyethyl Cellulose (140 Cps At 5%) - 393 mg/30mL . The currest status of Utimi Water Based Personal Lubricant drug is Active.
Drug Information:
| Drug NDC: | 82624-101 |
| 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: | Utimi Water Based Personal Lubricant |
| 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: | Personal Lubricant |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Shenzhen Guangdian Technology Co., Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | HYDROXYETHYL CELLULOSE (140 CPS AT 5%) - 393 mg/30mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RECTAL
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: | UNAPPROVED HOMEOPATHIC |
| 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: | 21 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 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. |
| 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 Guangdian 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. |
| UNII: | 8136Y38GY5
|
| 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 |
|---|
| 82624-101-03 | 30 mL in 1 BOTTLE (82624-101-03) | 21 Mar, 2022 | 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:
Indication for use utimi personal lubricant is a water-based lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication. this product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Product Elements:
Utimi water based personal lubricant personal lubricant sodium benzoate water polysorbate 20 glycerin propylene glycol hydroxyethyl cellulose (140 cps at 5%) hydroxyethyl cellulose (140 cps at 5%) lactic acid, dl- edetate disodium anhydrous
Indications and Usage:
Indications & usage utimi personal lubricant is a water-based lubricant for penile or vaginal application, intended to moisturize and enhance the ease and comfort of intimate sexual activity as well as supplement for the body's natural lubrication. this product is compatible with natural rubber latex, polyurethane and polyisoprene condoms. this product is not a contraceptive or spermicide.
Warnings:
Warnings if irriation or discomfort occurs, please discontinue to use and consult a physician. very slippery surfaces, clean the spills immediately. this product is not a contraceptive or spermicide. keep out of children and pets' reach.
Do Not Use:
Warnings if irriation or discomfort occurs, please discontinue to use and consult a physician. very slippery surfaces, clean the spills immediately. this product is not a contraceptive or spermicide. keep out of children and pets' reach.
Dosage and Administration:
Direction apply a small amount to genital areas. reapply as needed or desired.
Stop Use:
Stop use if irriation or discomfor occurs, please discontinue to use and consult a physician. very slippery surfaces, clean the spills immediately.
Dosage Forms and Strength:
Dosage forms & strengths the lubricant is like oil form. the active ingredient strength is 1.27% w/w.
Package Label Principal Display Panel:
Package label. principal display panel label
Further Questions:
Questions please contact us when you have any questions at service@utimi.com