POVIDONE-IODINE GEL SWABSTICK NON-STERILE- povidone iodine gel
Changzhou Maokang Medical Products Co. 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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MK Povidone- Iodine Gel Swabstick Non-Sterile

MK Povidone-Iodine Gel Swabstick Non-Sterile

Active Ingredient

Povidone-Iodine USP 10%

Purpose

Antiseptic

Use

Antiseptic skin preparation

Warnings

Do not use

if allergic to Iodine
in the eyes

Stop use and ask a doctor if

rednes, irritation, swelling or pain persists or increases
infection occurs

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid pooling beneath the patient

Ask a doctor before use if injuries are

deep puncture wounds
serious burns

Directions

apply product to skin as needed

Other Information

1% titratable
for hospital or professional use only

Inactive Ingredients

Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water

MK Povidone-Iodine Gel Swabstick

item

POVIDONE-IODINE GEL SWABSTICK NON-STERILE
povidone iodine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59050-250
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 g

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
NONOXYNOL-10 (UNII: K7O76887AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59050-250-10	2.3 g in 1 POUCH; Type 0: Not a Combination Product	11/05/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/05/2019

Labeler - Changzhou Maokang Medical Products Co. Ltd (421317073)

Name	Address	ID/FEI	Business Operations
Establishment
Changzhou Maokang Medical Products Co. Ltd		421317073	manufacture(59050-250)