Label: HANDS-FREE SURGICAL GEL gel
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Contains inactivated NDC Code(s)
NDC Code(s): 40796-003-01 - Packager: Jiangxi Baiyi Weishi Medical Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 May 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INDICATIONS & USAGE
1. Disinfect external hands: Wash and dry your hands and forearms with soap solution, then take about 5min of thisproduct. Rub the hands and forearms evenly for 3 minutes according to the (disinfection technical specifications). Bacteria gloves.
2. Take 3ml of this product's original solution and rub it with your hands for 1 minute during inspection, treatment and nursing of
patients.
3. Sanitize your hands after daily work: Take about 3ml of this product and rub your hands for 1 minute. - ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
1. Disinfectant for external use should not be taken orally
2. This product is used to clean dry hands
3. This product contains ethanol, which is iritating to damaged skin and mucous membranes. It is prohibited for those who are allergic to ethanol
4. Closed and stored in a cool, ventilated and dry place
5. Valid for 24 months - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HANDS-FREE SURGICAL GEL
hands-free surgical gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40796-003 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 325 mL in 500 mL PROPYL ALCOHOL (UNII: 96F264O9SV) (PROPYL ALCOHOL - UNII:96F264O9SV) PROPYL ALCOHOL 45 g in 500 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor Imprint Code economical Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40796-003-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/13/2020 Labeler - Jiangxi Baiyi Weishi Medical Technology Co., Ltd. (407967698) Establishment Name Address ID/FEI Business Operations Jiangxi Baiyi Weishi Medical Technology Co., Ltd. 407967698 manufacture(40796-003)
