NDC 81630-001 Wash-free Surgical Hand Disinfectant Gel II

Ethanol

NDC Product Code 81630-001

NDC 81630-001-02

Package Description: 10 BOX in 1 BOX > 10 BOTTLE, PLASTIC in 1 BOX (81630-001-09) > 60 mL in 1 BOTTLE, PLASTIC (81630-001-01)

NDC 81630-001-04

Package Description: 40 BOTTLE, PLASTIC in 1 BOX > 248 mL in 1 BOTTLE, PLASTIC (81630-001-03)

NDC 81630-001-06

Package Description: 25 BOTTLE, PLASTIC in 1 BOX > 500 mL in 1 BOTTLE, PLASTIC (81630-001-05)

NDC 81630-001-08

Package Description: 16 BOTTLE, PLASTIC in 1 BOX > 1000 mL in 1 BOTTLE, PLASTIC (81630-001-07)

NDC 81630-001-11

Package Description: 15 BOTTLE, PLASTIC in 1 BOX > 1000 mL in 1 BOTTLE, PLASTIC (81630-001-10)

NDC 81630-001-13

Package Description: 5 PACKAGE in 1 BOX > 5000 mL in 1 PACKAGE (81630-001-12)

NDC Product Information

Wash-free Surgical Hand Disinfectant Gel II with NDC 81630-001 is a a human over the counter drug product labeled by Shan Dong Lircon Medical Technology Co., Ltd. The generic name of Wash-free Surgical Hand Disinfectant Gel II is ethanol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Shan Dong Lircon Medical Technology Co., Ltd

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.

Product Type: Human Otc Drug 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.

Wash-free Surgical Hand Disinfectant Gel II Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 64.8 mL/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Shan Dong Lircon Medical Technology Co., Ltd
Labeler Code: 81630
FDA Application Number: part333A 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 03-12-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

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Wash-free Surgical Hand Disinfectant Gel II Product Label Images

Wash-free Surgical Hand Disinfectant Gel II Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Disinfectant Type

Antiseptic, Hand Sanitizer

Major Ingredient And Concentration

This product is a disinfectant gel with ethanol as the main active ingredient, and the ethanol content is 75%±7.5% v/v. Add skin care ingredients such as moisturizers and moisturizers.

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.

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 quickdisinfeotion 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.

Cautions

For external use only. Flammable. Keep away from heat or flame

Do Not Use

  • In children less than 2 months of age on open skin wounds

Otc - 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.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other Information

Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Carbomer, triethanolamine, glycerol, purified water.

Package

Package label is attached

* Please review the disclaimer below.