POVIDONE IODINE- povidone iodine 10% ointment 
Trifecta Pharmaceuticals USA LLC

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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Globe Povidone Iodine USP 10%

Active Ingredient

Povidone Iodine USP 10%

w/w (available iodine 1%)

Purpose

First Aid Antiseptic

Uses

First Aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external Use Only

Do not use

Directions

Ask Doctor before use if you have

Inactive Ingredients

Polyethylene glycol 400, Polyethylene glycol 4000

Questions?

Call 1-888-296-9067

Stop Use and Ask a doctor if

Storage Information

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222) right away.

Questions

1-888-296-9067

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

globe povidone iodine ointment 1oz CDER

POVIDONE IODINE 
povidone iodine 10% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-112-201 in 1 BOX12/23/2022
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/23/2022
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 1/2023
Document Id: f80cccd2-1511-2ddb-e053-6394a90aca81
Set id: f80ccd8a-9b9b-bbf9-e053-6394a90ac827
Version: 1
Effective Time: 20230109
 
Trifecta Pharmaceuticals USA LLC