Label: WASH-FREE SURGICAL HAND DISINFECTANT GEL II- ethanol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     81630-002-01, 81630-002-02, 81630-002-03, 81630-002-04, view more
    81630-002-05, 81630-002-06, 81630-002-07, 81630-002-08, 81630-002-09, 81630-002-10, 81630-002-11, 81630-002-12, 81630-002-13
  • Packager: Shan Dong Lircon 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 March 23, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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 attached81630-002-01

  • INGREDIENTS AND APPEARANCE
    WASH-FREE SURGICAL HAND DISINFECTANT GEL II 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81630-002
    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:81630-002-0310 in 1 BOX03/31/2021
    1NDC:81630-002-0210 in 1 BOX
    1NDC:81630-002-0160 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
    2NDC:81630-002-0540 in 1 BOX03/31/2021
    2NDC:81630-002-04248 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
    3NDC:81630-002-0725 in 1 BOX03/31/2021
    3NDC:81630-002-06500 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
    4NDC:81630-002-0916 in 1 BOX03/31/2021
    4NDC:81630-002-081000 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
    5NDC:81630-002-1115 in 1 BOX03/31/2021
    5NDC:81630-002-101000 mL in 1 BOTTLE, PLASTIC; Number of Units = ; Type 0: Not a Combination Product
    6NDC:81630-002-135 in 1 BOX03/31/2021
    6NDC:81630-002-125000 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 finalpart333A03/31/2021
    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(81630-002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!