Good Care Surgical Brush With Nail Cleaner
FDA Label NDC 50685-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dalian Goodwood Medical Care Ltd. for the product Good Care Surgical Brush With Nail Cleaner (NDC 50685-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

* Please review the disclaimer below.