BETADINE SOLUTION SWABSTICKS- povidone-iodine swab 
Purdue Products LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Betadine® Solution Swabsticks

Povidone-iodine Solution USP, 10%

Drug Facts

Active Ingredient Purpose

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

Purpose

Antiseptic

Uses

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

Other information

Inactive ingredients

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

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

L01119B 301880-0A

Betadine Solution Swabsticks
NDC 67618-153-01

Betadine Solution Swabsticks NDC 67618-153-01

Betadine Solution Swabsticks
NDC 67618-153-03

Betadine Solution Swabsticks NDC 67618-153-03
BETADINE  SOLUTION SWABSTICKS
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-153
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE.01 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-153-011 in 1 PACKET
2NDC:67618-153-033 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/1972
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Products LP (141916531)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Inc.107255002MANUFACTURE

Revised: 9/2011
Document Id: 0707b259-52a4-4ae6-b176-d093865906e7
Set id: 0707b259-52a4-4ae6-b176-d093865906e7
Version: 1
Effective Time: 20110915
 
Purdue Products LP