POVIDONE-IODINE PREP STERILE- povidone-iodine sponge

Povidone-Iodine Prep Sterile by

Drug Labeling and Warnings

Povidone-Iodine Prep 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 USP 10%

Purpose

Antiseptic

Use

• For preparation prior to surgery 
• Helps to reduce bacteria that can potentially cause skin infection.

Warnings

For external use only.

Do not apply to persons allergic to iodine

Do not use

• in the eyes

Ask a doctor before use if 

injuries are  deep wounds

puncture wounds  serious burns

Stop use and ask a doctor if

irritation and redness develop 

condition persists for more than 72 hours  infection occurs

Avoid pooling beneath the patient.Prolonged exposure to wet solution may cause skin irritation.

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 the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Other information

1% titratable iodine  latex free  for hospital or professional use only

Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP STERILE 
povidone-iodine sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59050-658
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 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59050-658-11	10 in 1 BOX	04/27/2015
1		2 in 1 POUCH
1		80 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/27/2015

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

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical Products Co., Ltd		421317073	manufacture(59050-658)