MAJOR POVIDONE IODINE- povidone-iodine ointment

Major Povidone Iodine by

Drug Labeling and Warnings

Major Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

Povidone Iodine USP10% w/w (available iodine 1%)

Purpose

Antiseptic-germicidal

Uses

for the treatment of:

• minor wounds
• infections
• kills bacteria promptly

Warnings

For external use only.

Do not use

• over large areas of the body
• if you are allergic to any of the ingredients
• longer than 1 week unless directed by a doctor

When using this product

• Avoid contact with eyes.

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• redness, irritation or swelling occurs or pain persists

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• apply directly to affected area
• may be bandaged

Other information

• Store at controlled room temperature 15°-30°C (59°-86°F).
• Close cap tightly after use.
• For control no. and expiration date, see carton and/or crimp of tube.
• Will not stain natural fabrics.
• Protect from freezing.

Inactive ingredients

glycerin, PEG-6, PEG-32, propylene glycol

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, Ml 48150 USA

Re-Oder No. 100433 M-101

Principal Display Panel – 1 oz. Tube

Major® NDC: 0904-1102-31

Povidine™

FIRST AID OINTMENT

NET WT. 1 OZ (28.35 g) *Compare to

POVIDINE – IODINE 10% Active Ingredient of

AVAILABLE IODINE 1% Betadine® Ointment

Principal Display Panel – 1 oz. Carton

Major® NDC: 0904-1102-31

Povidine™ *Compare to

FIRST AID OINTMENT Active Ingredient of

NET WT. 1OZ (28.35 g) POVIDINE - IODINE 10% Betadine® Ointment

INGREDIENTS AND APPEARANCE

MAJOR POVIDONE IODINE 
povidone-iodine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-1102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-1102-31	1 in 1 CARTON	08/14/2006
1		28.35 g 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 final	part333C	08/14/2006

Labeler - Major Pharmaceuticals (191427277)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(0904-1102)