WASH-FREE SURGICAL HAND DISINFECTANT GEL II- ethanol gel

Wash-Free Surgical Hand Disinfectant Gel II by

Drug Labeling and Warnings

Wash-Free Surgical Hand Disinfectant Gel II by is a Otc medication manufactured, distributed, or labeled by Shan Dong Lircon Medical Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

STOP USE

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

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

INGREDIENTS AND APPEARANCE

WASH-FREE SURGICAL HAND DISINFECTANT GEL II 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81630-003
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)	22.6 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81630-003-03	10 in 1 BOX	03/31/2021
1	NDC: 81630-003-02	10 in 1 BOX
1	NDC: 81630-003-01	60 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
2	NDC: 81630-003-05	40 in 1 BOX	03/31/2021
2	NDC: 81630-003-04	248 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
3	NDC: 81630-003-07	25 in 1 BOX	03/31/2021
3	NDC: 81630-003-06	500 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
4	NDC: 81630-003-09	16 in 1 BOX	03/31/2021
4	NDC: 81630-003-08	1000 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
5	NDC: 81630-003-11	15 in 1 BOX	03/31/2021
5	NDC: 81630-003-10	1000 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
6	NDC: 81630-003-13	5 in 1 BOX	03/31/2021
6	NDC: 81630-003-12	5000 mL in 1 PACKAGE; Number of Units = ; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2021

Labeler - Shan Dong Lircon Medical Technology Co., Ltd (529169607)

Registrant - Shan Dong Lircon Medical Technology Co., Ltd (529169607)

Establishment
Name	Address	ID/FEI	Business Operations
Shan Dong Lircon Medical Technology Co., Ltd		529169607	manufacture(81630-003)