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  5. Label Information: Good Care Surgical Brush With Nail Cleaner

FDA Label for Good Care Surgical Brush With Nail Cleaner

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. OTHER
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Good Care Surgical Brush With Nail Cleaner Product Label

The following document was submitted to the FDA by the labeler of this product Dalian Goodwood Medical Care Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient

Povidone Iodine USP, 7.5% w/v

(minimum available Iodine 0.75%) w/w


Otc - 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.


Otc - Do Not Use



Do not use if redness or irritation ocurrs

Otc - Stop Use



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


Otc - 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


Other



Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

Made in China      www.dl-goodwood.com


Package Label.Principal Display Panel



Good CareSurgical Scrub Brush/ Sponge With Nail Cleaner GW1503Povidone-Iodine

PIS1 - SurgicalScrubPovidoneIodine75

PIS1 - SurgicalScrubPovidoneIodine75


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