BETADINE- povidone-iodine swab

Betadine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Povidone-iodine Solution USP, 10% (equal to 1% available iodine)

Purpose

Antiseptic

Uses

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

Warnings

For external use only

Do not use this product

• in the eyes
• if you are allergic to iodine or other product ingredients

When using this product

• prolonged exposure may cause irritation or, rarely, severe skin reactions

Stop using this product

• if irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
• in rare instances of local irritation or sensitivity

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• tear slit; pull top of packette up and away, exposing pad
• use pad to swab area thoroughly
• repeat using the other side if necessary
• use one time only. Each packette contains 1 Swab Aid Antiseptic pad.

Other information

• store between 20°-25°C (68°-77°F). Avoid freezing and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT

Inactive ingredients citric acid, disodium phosphate, nonoxynol-9, purified water, sodium hydroxide

SPL UNCLASSIFIED SECTION

©2013, Purdue Products L.P.

Dist by: Purdue Products L.P.
Stamford, CT 06901-3431
300983-0D

PRINCIPAL DISPLAY PANEL

Betadine Solution Swab Aid Antiseptic Pads - Carton
NDC 67618-152-01

INGREDIENTS AND APPEARANCE

BETADINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-152
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 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-152-01	100 in 1 CARTON
1		0.01 mL in 1 PACKET; 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	04/01/1992

Labeler - Purdue Products LP (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Inc		107255002	MANUFACTURE(67618-152)