WASH-FREE SURGICAL HAND DISINFECTANT GEL II- ethanol gel 
Shan Dong Lircon Medical Technology Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPL file for drug listing

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

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.

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.

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 attached81630-001-02

WASH-FREE SURGICAL HAND DISINFECTANT GEL  II
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81630-001
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL64.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.3 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 32.8 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81630-001-0210 in 1 BOX03/12/2021
1NDC:81630-001-0910 in 1 BOX
1NDC:81630-001-0160 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
2NDC:81630-001-0440 in 1 BOX03/12/2021
2NDC:81630-001-03248 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
3NDC:81630-001-0625 in 1 BOX03/12/2021
3NDC:81630-001-05500 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
4NDC:81630-001-0816 in 1 BOX03/12/2021
4NDC:81630-001-071000 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
5NDC:81630-001-1115 in 1 BOX03/12/2021
5NDC:81630-001-101000 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
6NDC:81630-001-135 in 1 BOX03/12/2021
6NDC:81630-001-125000 mL in 1 PACKAGE; Number of Units = ; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/12/2021
Labeler - Shan Dong Lircon Medical Technology Co., Ltd (529169607)
Registrant - Shan Dong Lircon Medical Technology Co., Ltd (529169607)
Establishment
NameAddressID/FEIBusiness Operations
Shan Dong Lircon Medical Technology Co., Ltd529169607manufacture(81630-001)

Revised: 12/2022
Document Id: ea824804-fc93-47ae-bc50-706155a8ef91
Set id: 7eab998d-b6ab-482f-a6ac-e314f8f2a0a5
Version: 2
Effective Time: 20221226
 
Shan Dong Lircon Medical Technology Co., Ltd