POVIDONE-IODINE 10%- povidone-iodine solution

povidone-iodine 10% by

Drug Labeling and Warnings

povidone-iodine 10% by is a Otc medication manufactured, distributed, or labeled by BIONPHARMA INC., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Purpose

First aid antiseptic

Uses

first aid to help prevent infection in minor cuts scrapes burns

Warnings

For exmrnal use only

Do not use

in the eyes over large areas of the body

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

the condition persists or gets worse you need to use this product for more than 1 week

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the affected area
apply a small amount of product to the area 1 to 3 times daily
may be covered with a sterile bandage it bandaged, let dry first

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water and sodium hydroxide

Questions or comments?

1-888-235-2466

SPL UNCLASSIFIED SECTION

Manufactured for:

Bionpharma Inc.,
Princeton, NJ 08540

**This product is not manufactured or dislributed by the owners of Betadine ®

L0001034
R0425

8 fl oz (237 mL) Bottle

** compare to the active ingredient in Betadine®

a+ health TM

first aid

antiseptic

povidone-

iodine 10%

topical solution USP

helps prevent infection

in minor cuts, scrapes & burns

8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 10% 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-483-93	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	10/06/2025

Labeler - BIONPHARMA INC. (079637826)

Registrant - BIONPHARMA INC. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(69452-483)