Label: (QIQING) CHLORHEXIDINE GLUCONATE ALCOHOL DISINFECTANT- alcohol liquid

  • 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 May 15, 2020

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  • Purpose

    Antiseptic-Antiseptic

    Active Ingredient(s)

    Alcohol 63%-77% v/v. Purpose: Antiseptic

    Chlorhexidine Gluconate 0.45%-0.55% w/v Purpose: Antiseptic

  • Use

    • surgical hand antiseptic: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
    • healthcare personnel hand antiseptic: hand rub to help reduce bacteria that potentially can cause disease
    • recommended for repeated use
  • Warnings

    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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    50 mL NDC: 77919-001-01

    60 mL NDC: 77919-001-02

    100 mL NDC: 77919-001-03 100ml

    250 mL NDC: 77919-001-04

    500 mL NDC: 77919-001-05

    1000 mL NDC: 77919-001-06

  • INGREDIENTS AND APPEARANCE
    (QIQING) CHLORHEXIDINE GLUCONATE ALCOHOL DISINFECTANT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77919-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.45 mg  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77919-001-0150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    2NDC:77919-001-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    3NDC:77919-001-03100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    4NDC:77919-001-04250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    5NDC:77919-001-05500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    6NDC:77919-001-061000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Qingdao precision medical technology co., LTD. Zibo branch (554534589)
    Registrant - Qingdao precision medical technology co., LTD. Zibo branch (554534589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qingdao precision medical technology co., LTD. Zibo branch554534589manufacture(77919-001)
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