BETADINE- povidone-iodine spray

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Purdue Products LP, Thatcher Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

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

Purpose

Antiseptic

Uses

Patient pre-operative skin preparation

• for preparation of the skin prior to surgery
• helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Do not use

• in the eyes
• If you are allergic to povidone-iodine or any other ingredients in this preparation

When using this product

• prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
• in pre-operative prepping, avoid “pooling” beneath the patient

Stop use and ask a doctor if

• irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

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

Directions

• hold container about 4-6 inches from skin
• spray desired area n allow to dry
• may be bandaged
• replace cap after use

Other information

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F). Do not freeze.

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Dist. by: Purdue Products L.P., Stamford, CT 06901-3431
301821-0B

PRINCIPAL DISPLAY PANEL

Betadine Spray
NDC: 67618-148-03

INGREDIENTS AND APPEARANCE

BETADINE 
povidone-iodine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-148
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	.05 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (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: 67618-148-03	89 mL in 1 BOTTLE

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

Labeler - Purdue Products LP (141916531)

Establishment
Name	Address	ID/FEI	Business Operations
Thatcher Company		041307356	MANUFACTURE