Label: CHLORHEXIDINE GLUCONATE APPLICATOR solution

  • 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 February 24, 2020

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  • Active ingredients

    Chlorhexidine gluconate,（ 2% solution ） ，
    Isopropyl alcohol,（ 70% solution ）

  • ask a doctor

    If any irritation or allergic reaction occurs

  • Do not use

    ■ If any open wounds
    ■ If package damaged or expired
    ■ If the patient is allergic to chlorhexidine gluconate or any other ingredient in this product

  • Keep out of the reach of children

    Keep out of the reach of children

  • Purpose

    Antiseptic

  • Stop use and ask a doctor

    If any irritation or allergic reaction occurs

  • Inactive ingredient

    ■ Water

  • Other information

    ■ Stored between 4-30℃
    Avoid exclusive heat above 40℃ (104° F)

  • Directions

    Peel apart the package and remove the applicator
    Pull and remove the ring collar lock from the handle
    Wet the treatment area with the fluid
    Press down the handle to activate and release the solution flow into the sponge pad

  • Use

    For skin preparation before surgery

  • Warnings

    ■ Single-use product
    ■ Keep away from flames or sparks
    ■ Keep out of the reach of children

  • LABEL

    10.5g26g

  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE APPLICATOR 
    chlorhexidine gluconate applicator solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73565-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73565-011-2626 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/17/2020
    2NDC:73565-011-1010.5 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/17/2020
    Labeler - Miraclean Technology Co.,Ltd (529423940)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miraclean Technology Co.,Ltd529423940manufacture(73565-011)
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