BETADINE- povidone-iodine spray

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma LP, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Povidone-iodine, 5% (0.5% available iodine).

PURPOSE

Purpose

First aid antiseptic

INDICATIONS & USAGE

Uses first aid to help prevent infection in minor

• cuts
• scrapes
• burns

INDICATIONS & USAGE

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

DO NOT USE

Ask a doctor before use if you have

• deep or puncture wounds
• serious burns
• animal bites

STOP USE

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

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

WHEN USING

Directions

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

HOW SUPPLIED

Other information

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

INACTIVE INGREDIENT

Inactive ingredients citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water

Dist. by: Avrio Health L.P.
Stamford, CT 06901-3431

304882-0A

©2018 Avrio Health L.P.

DOSAGE FORMS & STRENGTHS

DOSAGE & ADMINISTRATION

WARNINGS

PRINCIPAL DISPLAY PANEL

Betadine Spray
NDC: 67618-160-03

INGREDIENTS AND APPEARANCE

BETADINE 
povidone-iodine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-160
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-160-03	1 in 1 CARTON	04/15/1992
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/15/1992

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Thatcher Company		041307356	MANUFACTURE(67618-160)