POVIDONE-IODINE SOLUTION STERILE- povidone-iodine liquid

Povidone-Iodine Solution Sterile by

Drug Labeling and Warnings

Povidone-Iodine Solution Sterile 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]

Drug Facts

Active ingredient

Povidone-Iodine 10%

Purpose

First aid antiseptic

Use

for antiseptic skin preparation

Warnings

do not use

• if allergic to Iodine
• do not use in the eye

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

Keep out of reavh of children.

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

Avoid pooling beneath patient.

Ask a doctor before use if injuries are

• deep or punture wounds
• serious burns

Directions

Apply product to skin as needed.

Other information

• 1% titratable iodine
• for hospital or professional use only

Inactive ingredients:

Alkyl glucoside,citric acid,glycerin, hydroxyethyl cellulose,nonoxynol-10, potassium iodide, purified water, hydroxode

Package Labeling:

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE SOLUTION STERILE 
povidone-iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59050-554
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
NONOXYNOL-10 (UNII: K7O76887AP)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59050-554-11	30 mL in 1 POUCH; Type 0: Not a Combination Product	10/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/22/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical Products Co., Ltd		421317073	manufacture(59050-554)