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

  • NDC Code(s): 50685-004-01
  • 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 October 1, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Povidone Iodine USP, 10% w/v

    (minimum available Iodine 1%) w/w

    Close
  • PURPOSE

    Purpose

    Surgical Hand Scrub

    Close
  • 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.

    Close
  • WARNINGS

    Warnings

    For external use only.

    Close
  • DO NOT USE

    Do not use if redness or irritation ocurrs

    Close
  • STOP USE

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

    Close
  • 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.

    Close
  • 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
    Close
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

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

    Close
  • SPL UNCLASSIFIED SECTION

    Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

    Made in China      www.dl-goodwood.com

    Close
  • PRINCIPAL DISPLAY PANEL

    Good Care


    Surgical Scrub Brush/ Sponge With Nail Cleaner GW1503
    Povidone-Iodine
    Close
  • INGREDIENTS AND APPEARANCE
    GOOD CARE SURGICAL BRUSH WITH NAIL CLEANER 
    povidone-iodine sponge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50685-004
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 10 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50685-004-01 15 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/01/2010
    Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
    Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
    Establishment
    Name Address ID/FEI Business Operations
    Dalian Goodwood Medical Care Ltd. 529575699 manufacture
    Close