GOOD CARE SURGICAL BRUSH WITH NAIL CLEANER- povidone-iodine sponge
Dalian Goodwood Medical Care Ltd.

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.

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Surgical Scrub Brush/Sponge With Nail Cleaner Povidone Iodine

Active Ingredient

Povidone Iodine USP, 10% w/v

(minimum available Iodine 1%) w/w

Purpose

Surgical Hand Scrub

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

For external use only.

Do not use if redness or irritation occur

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

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

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

Other information

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

Inactive ingredients

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

Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

Made in China www.dl-goodwood.com

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

PIS1

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50685-004-01	15 mL in 1 POUCH; Type 0: Not a Combination Product	10/01/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2010

Labeler - Dalian Goodwood Medical Care Ltd. (529575699)

Registrant - Dalian Goodwood Medical Care Ltd. (529575699)

Name	Address	ID/FEI	Business Operations
Establishment
Dalian Goodwood Medical Care Ltd.		529575699	manufacture(50685-004)

Revised: 12/2020

Document Id: b72389b0-ed37-1dce-e053-2a95a90a8193

Set id: 553f0d58-5198-49cb-beb1-cfe86d907254

Version: 4

Effective Time: 20201223

Dalian Goodwood Medical Care Ltd.