BETADINE SOLUTION- povidone-iodine solution 
Atlantis Consumer Healthcare, Inc.

----------

BETADINE® Solution
10% Povidone-iodine

Drug Facts

Active ingredient

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

Purpose

First aid antiseptic

Uses

First aid to helpprevent infection in minor

WarningsFor 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, getmedical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients

citric acid, disodiumphosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

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

305541-0D

BetadineSolution 6 fl oz Bottle
NDC: 67618-150-18

Betadine Solution 6fl oz Bottle

BetadineSolution 8 fl oz Bottle
NDC: 67618-150-08 Betadine Solution Bottle

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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-150-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
2NDC:67618-150-18177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00306/01/1980
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 4/2024
Document Id: 1597c677-ff0b-7c28-e063-6294a90ae050
Set id: 1b1e224c-8c00-46ea-9bdd-020a9b45321d
Version: 5
Effective Time: 20240408
 
Atlantis Consumer Healthcare, Inc.