STERILE- povidone-iodine patch

sterile by

Drug Labeling and Warnings

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-lodine 10%w/w

Purpose

Antiseptic

Use

for antiseptic skin preparation

Warnings

do not use

• if allergic to lodine
• 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 reach 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 puncture wounds
• serious burns

Driections

apply locally as needed

Other information

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

Inactive ingredients:

Citrc Acid, Alkyl Glucoside, Hydroxyethy, Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium lodide, Purifed Water.

Package Labeling:

INGREDIENTS AND APPEARANCE

STERILE 
povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59050-552
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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: 59050-552-11	22.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	06/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/29/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical Products Co., Ltd		421317073	manufacture(59050-552)