STERILE- povidone-iodine solution

sterile by

Drug Labeling and Warnings

sterile by is a Otc medication manufactured, distributed, or labeled by Asia Dynamics Inc., d/b/a ADI Medical, Changzhou Maokang Medical Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-lodine USP 10%

Purpose

Antiseptic

Use

for antiseptic skin preparation

Warnings

For external use only

Avoid pooling beneath patient

do not use

• if allergic to lodine
• 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.

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns

Directions

apply locally as needed

Other information

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

Inactive ingredients:

Nonyl Nonoxynol-10, Glycerin, Purifed Water.

Storage

Avoid excessive heat

Store at room temperature

Package Labeling:

NDC: 83645-552-11

ADI Medical

INGREDIENTS AND APPEARANCE

STERILE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83645-552
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
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83645-552-11	22.5 g in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	09/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/27/2023

Labeler - Asia Dynamics Inc., d/b/a ADI Medical (607022126)

Registrant - Asia Dynamics Inc., d/b/a ADI Medical (607022126)

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical Products Co., Ltd		421317073	manufacture(83645-552)