FDA Label for Wash-free Surgical Hand Disinfectant Gel II
View Indications, Usage & Precautions
Wash-free Surgical Hand Disinfectant Gel II Product Label
The following document was submitted to the FDA by the labeler of this product Shan Dong Lircon Medical Technology Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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.
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.