BETADINE  SOLUTION SWABSTICKS- povidone-iodine solution 
Avrio Health L.P.

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 Swabstick
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

When using this product

Stop using this product

Keep out of reach of children.

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

Directions

Other information

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

Inactive ingredients

purified water, sodium hydroxide

Dist. by:
Avrio Health L.P.
Stamford, CT 06901-3431

Betadine Swabsticks — 1 Swab
NDC: 67618-153-01

NDC 67618-153-01

Betadine Swabsticks — 3 Swabs
67618-153-03

NDC 67618-153-03
BETADINE   SOLUTION SWABSTICKS
povidone-iodine solution
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) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-153-011 in 1 POUCH09/15/1972
11.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:67618-153-033 in 1 POUCH09/15/1972
21.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/1972
Labeler - Avrio Health L.P. (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Professional Disposables International, Inc. 800777117MANUFACTURE(67618-153)

Revised: 3/2022
Document Id: 52ec00e0-1795-4d5d-8a52-eba61363aced
Set id: 0707b259-52a4-4ae6-b176-d093865906e7
Version: 4
Effective Time: 20220322
 
Avrio Health L.P.