POVIDONE-IODINE PAINT SOLUTION- povidone-iodine solution

Povidone-Iodine Paint Solution by

Drug Labeling and Warnings

Povidone-Iodine Paint Solution by is a Otc medication manufactured, distributed, or labeled by Changzhou Maokang Medical Products Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MK Povidone-Iodine Paint Solution

Active Ingredient

Povidone-Iodine 10%

Purpose

Antiseptic

Use

Antiseptic skin preparation

Warnings

Do not use

• if allergic to Iodine
• in the eyes

Stop use and ask doctor if

• redness, 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 locally as needed

Other Information

• 1% titratable
• for hospital or professional use only

Inactive Ingredients

alkyl glucoside, anhydrous citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, sodium hydroxide, purified water

MK Povidone-Iodine Paint Solution

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PAINT SOLUTION 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59050-551
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	11 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59050-551-44	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
2	NDC: 59050-551-42	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/10/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical Products Co.,Ltd		421317073	manufacture(59050-551)