BETADINE SOLUTION SWABSTICKS- povidone-iodine swab

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Atlantis Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient Purpose

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

Purpose

Antiseptic

Uses

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

• in rare instances of local irritation or sensitivity
• if irritation and redness develop and continue for more than 72 hours

Keep out of reach of children

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

Directions

• tear at slit; pull top of packette across, exposing end of swabstick
• remove Betadine Solution Swabstick and apply as needed
• use one time only

Other information

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

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

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

L01119B 301880-0A

PRINCIPAL DISPLAY PANEL

Betadine Solution Swabsticks
NDC: 67618-153-01

PRINCIPAL DISPLAY PANEL

Betadine Solution Swabsticks
NDC: 67618-153-03

INGREDIENTS AND APPEARANCE

BETADINE  SOLUTION SWABSTICKS
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	.01 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-153-01	1 in 1 PACKET
2	NDC: 67618-153-03	3 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/15/1972

Labeler - Purdue Products LP (141916531)

Registrant - Purdue Products LP (141916531)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Inc.		107255002	MANUFACTURE