Label: WASH-FREE SURGICAL HAND DISINFECTANT GEL II- ethanol gel
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NDC Code(s):
81630-003-01,
81630-003-02,
81630-003-03,
81630-003-04, view more81630-003-05, 81630-003-06, 81630-003-07, 81630-003-08, 81630-003-09, 81630-003-10, 81630-003-11, 81630-003-12, 81630-003-13
- Packager: Shan Dong Lircon Medical Technology Co., Ltd
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 16, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Disinfectant type
- Major ingredient and concentration
- Germicidal spectrum
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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
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- Inactive ingredients
- package
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INGREDIENTS AND APPEARANCE
WASH-FREE SURGICAL HAND DISINFECTANT GEL II
ethanol gelProduct 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)