BETADINE SOLUTION- 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
10% Povidone-iodine

Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Purpose

Antiseptic

Uses

Patient pre-operative skin preparation

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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

Directions

Other information

Inactive ingredients

pareth 25-9, purified water, sodium hydroxide

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

©2018, Avrio Health L.P.

Betadine Solution 8 oz
NDC: 67618-150-09

Betadine Solution 8 oz
BETADINE  SOLUTION
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-150
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
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
C12-15 PARETH-9 (UNII: H3ZIY6WP1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-150-09237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
2NDC:67618-150-0514.8 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
3NDC:67618-150-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
4NDC:67618-150-17473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
5NDC:67618-150-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/198008/31/2024
6NDC:67618-150-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/1980
Labeler - Avrio Health L.P. (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Thatcher Company041307356MANUFACTURE(67618-150)

Revised: 10/2022
Document Id: 6881a122-3254-43fd-b77e-664f15d251f9
Set id: 41891599-420e-48d2-8e31-d28a2209e383
Version: 7
Effective Time: 20221004
 
Avrio Health L.P.