Label: CHLORA-CLEANZE- chlorhexidine gluconate and isopropyl alcohol swab

  • 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 July 5, 2017

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  • ACTIVE INGREDIENT

    Active ingredients

    Chlorhexidine gluconate 2% w/v

    Isopropyl alcohol 70% v/v

  • PURPOSE

    Purposes
    Antiseptic

  • WARNINGS

    Warnings
    For external use only. Flammable keep away from fire or flame.

    • do not use with electrocautery procedures

    Do not use

    • On patients with allergies to Chlorhexidine gluconate or Isopropyl alcohol
    • As a general skin cleanser or on open wounds
  • STOP USE

    Stop use immediately if irritation or allergic reaction occurs. Contact your doctor immediately!

  • DOSAGE & ADMINISTRATION

    Directions

    • The maximum treatment area is 2.5” x 2.5”
    • Point directional arrow downward
    • Hold applicator at both ends firmly and with a flexible firm motion break center seal at perforations.
    • Remove side of applicator case with applicator tip and discard other side according to institutional

    procedures.

    • Apply solution to site using lateral stokes in both directions. (30 seconds for dry sites and 2

    minutes for moist sites)

    • Allow area to dry sufficiently. Dry sites for 30 seconds and moist areas for 1 minute.
    • Single use only. Discard remaining solution. Entire solution is not required to be used
  • INACTIVE INGREDIENT

    Inactive ingredients USP purified water

  • INDICATIONS & USAGE

    Use prior to surgery to prepare patient’s skin. Helps in the reduction of potentially harmful bacteria which can cause skin infections.

  • STORAGE AND HANDLING


    Other information
    ■ store between 15–30 °C (59–86 °F)
    ■ avoid freezing and excessive heat above 40 °C (104 °F)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children contact Poison Control or get medical help immediately.

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    CHLORA-CLEANZE 
    chlorhexidine gluconate and isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71389-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71389-001-010.67 mL in 1 POUCH; Type 0: Not a Combination Product04/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/18/2017
    Labeler - Biotronix Healthcare Industries, Inc. (065762392)
    Registrant - US MED PHARM SUPPLIES, INC. (831533109)
    Establishment
    NameAddressID/FEIBusiness Operations
    Longood Medicine (Beijing) Co., Ltd.529553064manufacture(71389-001)
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