BETADINE- 10% povidone-iodine liquid

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc, Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Povidone-iodine, 10%

Purpose

First aid antiseptic

Uses

first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns

Warnings

For external use only
Do not use ■ in the eyes ■ over large areas of the body ■ if you are

allergic to povidone-iodine or any other ingredients in this preparation
Ask a doctor before use if you have ■ deep or puncture wounds
■ serious bums ■ animal bites
Stop use and ask a doctor if ■ the condition persists or gets worse
■ you need to use this product for more than 1 week

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
■ if bandaged, let dry first

Other Information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

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

Questions?

1-833-288-2684

Principle Display Panel

Betadine Antiseptic

67618-150-18

Betadine Antiseptic

67618-150-08

INGREDIENTS AND APPEARANCE

BETADINE 
10% povidone-iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-0150
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0150-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/06/2024
2	NDC: 0116-0150-18	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	11/06/2024

Labeler - Xttrium Laboratories, Inc (007470579)

Registrant - Xttrium Laboratories, Inc (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0150)