BETADINE- povidone-iodine spray 
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® Spray
5% Povidone-iodine

Drug Facts

Active ingredients

Povidone-iodine, 5% (0.5% available iodine)

Purpose

First aid Antiseptic

Uses

First aid to help prevent infection in minor

Warnings

For external use only

Do not use

Ask a doctor before use if you have

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

store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do Not Freeze

Inactive ingredients

citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodate, purified water, sodium hydroxide

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

Betadine 3 oz Spray
NDC: 67618-160-03

Betadine 3 oz Spray Label
BETADINE 
povidone-iodine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POTASSIUM IODATE (UNII: I139E44NHL)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-160-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/1992
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/15/1992
Labeler - Avrio Health L.P. (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114MANUFACTURE(67618-160)

Revised: 6/2022
Document Id: db1f690d-7837-465a-a86b-91b8581bbd4b
Set id: f9939dca-cd07-3200-a95b-177a771585af
Version: 7
Effective Time: 20220607
 
Avrio Health L.P.