Label: GOOD CARE SURGICAL BRUSH WITH NAIL CLEANER- povidone-iodine sponge

  • NDC Code(s): 50685-005-01
  • Packager: Dalian Goodwood Medical Care 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 25, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Povidone Iodine USP, 7.5% w/v

    (minimum available Iodine 0.75%) w/w

  • PURPOSE

    Purpose

    Surgical Hand Scrub

  • INDICATIONS & USAGE

    Use

    Preoperative cleaning of healthcare personnel arms and hands. Significantly reduces the number of micro-organisms on the hands forearms prior to the surgery.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use if redness or irritation occur

  • STOP USE

    Stop use and ask a doctor if severe adverse reactions occur.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean under nails with nail pick
    • Wet hands and forearms
    • Scrub thoroughly for 3 minutes paying particular attention to the nail, cuticle and interdigital spaces
    • Repeat scrub for 3 more minutes
    • Rinse thoroughly
  • STORAGE AND HANDLING

    Other information

    • Avoid excessive heat 40 degrees C (104 degrees F)
    • Discard after single use
  • INACTIVE INGREDIENT

    Inactive ingredients

    ammonium nonoxynol sulfate, disodium phosphate, hydrogen peroxide, octoxynol, phosphoric acid, sodium hydroxide, USP water

  • SPL UNCLASSIFIED SECTION

    Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

    Made in China www.dl-goodwood.com

  • PRINCIPAL DISPLAY PANEL

    Good Care

    Surgical Scrub Brush/ Sponge With Nail Cleaner GW1503
    Povidone-Iodine

  • PRINCIPAL DISPLAY PANEL

    PIS1

  • INGREDIENTS AND APPEARANCE
    GOOD CARE SURGICAL BRUSH WITH NAIL CLEANER 
    povidone-iodine sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50685-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50685-005-0115 mL in 1 POUCH; Type 0: Not a Combination Product10/01/201004/30/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/201004/30/2026
    Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
    Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Goodwood Medical Care Ltd. 529575699manufacture(50685-005)
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