BETADINE CREAM- povidone-iodine cream

Betadine Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient Purpose
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

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

WHEN USING

Directions

• clean the affected area
• apply a small amount of product (equal to the surface area of a fingertip) to the area 1 to 3 times daily
• may be covered with a sterile bandage

HOW SUPPLIED

Other information

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

INACTIVE INGREDIENT

Inactive ingredients
cetostearyl alcohol,glycerin, mineral oil, PEG-50 stearate, polysorbate 60, potassium iodate, sodium hydroxide, sorbitan monostearate, water, white petrolatum

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

305099-0A

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

Betadine Cream
NDC: 67618-180-12

INGREDIENTS AND APPEARANCE

BETADINE CREAM 
povidone-iodine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
cetostearyl alcohol (UNII: 2DMT128M1S)
glycerin (UNII: PDC6A3C0OX)
mineral oil (UNII: T5L8T28FGP)
PEG-50 stearate (UNII: 776CJK5X56)
polysorbate 60 (UNII: CAL22UVI4M)
potassium iodate (UNII: I139E44NHL)
sodium hydroxide (UNII: 55X04QC32I)
sorbitan monostearate (UNII: NVZ4I0H58X)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-180-12	1 in 1 CARTON	06/01/1980
1		15 mL in 1 TUBE; 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	06/01/1980

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Mundipharma Pharmaceuticals Limited		365982441	MANUFACTURE(67618-180)