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

Antiseptic

Uses

Patient pre-operative skin preparation

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctorif

Keep out of reach of children.
If swallowed, get medical help or contact a Poison ControlCenter 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.

BetadineSolution 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 DrugM00306/01/1980
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 12/2023
Document Id: 37e362bf-7993-439f-8505-2c700e7d3f6f
Set id: 41891599-420e-48d2-8e31-d28a2209e383
Version: 9
Effective Time: 20231222
 
Atlantis Consumer Healthcare, Inc.