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:

Label NDC 83645-552-11

ADI Medical

ADI MEDICAL PVP-I POUCH, FOIL
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83645-550
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83645-550-11	50 in 1 CASE	09/27/2023
1		22.5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	09/27/2023

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

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

Povidone-Iodine Solution, sterile