BETADINE- povidone-iodine spray 
Atlantis Consumer Healthcare, Inc.

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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 aidto help prevent infection in minor

Warnings

For external use only

Do not use

Ask a doctor before useif 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 Centerright away.

Directions

Other information

store at25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do NotFreeze

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 3oz Spray
NDC: 67618-160-03

Betadine Spray
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 DrugM00304/15/1992
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 12/2023
Document Id: 136d25e5-5ccc-4a69-ab9d-35b02cefed5b
Set id: f9939dca-cd07-3200-a95b-177a771585af
Version: 9
Effective Time: 20231222
 
Atlantis Consumer Healthcare, Inc.