BETADINE- povidone-iodine liquid

Betadine by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-iodine, 5%

PURPOSE

First aid antiseptic

INDICATIONS & USAGE

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

WARNINGS

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 burns ■ 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Do Not Freeze

INACTIVE INGREDIENT

pareth 25-9, purified water, sodium hydroxide

QUESTIONS

1-833-288-2684

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BETADINE 
povidone-iodine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-0160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-15 PARETH-9 (UNII: H3ZIY6WP1R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0160-03	88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	11/07/2024

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0160)