Wash-free Surgical Hand Disinfectant Gel Ii
Ethanol
Shan Dong Lircon Medical Technology Co., Ltd
Human Otc Drug
NDC 81630-003Wash-free Surgical Hand Disinfectant Gel Ii also known as Ethanol is a human otc drug labeled by 'Shan Dong Lircon Medical Technology Co., Ltd'. National Drug Code (NDC) number for Wash-free Surgical Hand Disinfectant Gel Ii is 81630-003. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Wash-free Surgical Hand Disinfectant Gel Ii drug includes Alcohol - 75 mL/100mL . The currest status of Wash-free Surgical Hand Disinfectant Gel Ii drug is Active.
Drug Information:
| Drug NDC: | 81630-003 |
| 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: | Wash-free Surgical Hand Disinfectant Gel Ii |
| 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: | Ethanol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Shan Dong Lircon Medical 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: | ALCOHOL - 75 mL/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 31 Mar, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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: | Shan Dong Lircon Medical Technology Co., Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1305100
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3K9958V90M
|
| 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 |
|---|
| 81630-003-03 | 10 BOX in 1 BOX (81630-003-03) / 10 BOTTLE, PLASTIC in 1 BOX (81630-003-02) / 60 mL in 1 BOTTLE, PLASTIC (81630-003-01) | 31 Mar, 2021 | N/A | No |
| 81630-003-05 | 40 BOTTLE, PLASTIC in 1 BOX (81630-003-05) / 248 mL in 1 BOTTLE, PLASTIC (81630-003-04) | 31 Mar, 2021 | N/A | No |
| 81630-003-07 | 25 BOTTLE, PLASTIC in 1 BOX (81630-003-07) / 500 mL in 1 BOTTLE, PLASTIC (81630-003-06) | 31 Mar, 2021 | N/A | No |
| 81630-003-09 | 16 BOTTLE, PLASTIC in 1 BOX (81630-003-09) / 1000 mL in 1 BOTTLE, PLASTIC (81630-003-08) | 31 Mar, 2021 | N/A | No |
| 81630-003-11 | 15 BOTTLE, PLASTIC in 1 BOX (81630-003-11) / 1000 mL in 1 BOTTLE, PLASTIC (81630-003-10) | 31 Mar, 2021 | N/A | No |
| 81630-003-13 | 5 PACKAGE in 1 BOX (81630-003-13) / 5000 mL in 1 PACKAGE (81630-003-12) | 31 Mar, 2021 | 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:
Germicidal spectrum antiseptic, hand sanitizer. it can kill the microorganisms such as enter ic pathogenic bacteria, pyogenic coccus, pathogenic yeast and hospital infect ion common germs.
Product Elements:
Wash-free surgical hand disinfectant gel ii ethanol alcohol alcohol carbomer homopolymer, unspecified type trolamine glycerin water
Indications and Usage:
Application soope 1. sanitary hand disinfeotion: suitable for hand disinfeotion of medical staff in out patient?linios, wards, emergency room. intensive care units?hemodialysis rooms, and endoscopy rooms of medical and health institutions. it is suitable for quick disinfeotion of hands of persons who need to perform hand hygiene. 2. surgical hand disinfection: suitable for preoperative surgical hand disinfection in the operating room of medical and health inst itutions.
Warnings:
Cautions for external use only. flammable. keep away from heat or flame
Do Not Use:
Cautions for external use only. flammable. keep away from heat or flame
When Using:
When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thoroughly with water. stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Usage sanitary hand disinfection: take an appropriate amount of disinfectant gel (2-3ml) on the palm, rub your hands together to make it evenly spread on each part (ensure that the liquid covers the entire surface), follow the ws/t313 "specification of hand hygiene for health care workers " appendix a, the method of hand washing for medical workers, rub and disinfect for 1 minute. surgical hand disinfection?1. wash hands and forearms, rinse thoroughly and dry. 2. take an appropriate amount of disinfectant gel (5-10ml), follow the ws/t313 "specification of hand hygiene for health care workers " appendix c surgical no-wash disinfection method, rub your hands and forearms to the lower third of the upper arms for 3 minutes.wear sterile gloves after drying.
Stop Use:
Stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.
Package Label Principal Display Panel:
Package package label is attached 81630-003-01