TM TITUS MEDICAL POVIDONE IODINE- povidone-iodine ointment 
Titus Medical LLC

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81526-002

Active Ingredient

Povidone-Iodine USP (10%)

Purpose

Antiseptic

Uses

Antiseptic skin preparation

Warnings

For external use only

Do not use if allergic to iodine in the eyes

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

Ask a doctor before use if injuries are deep wounds, puncture wounds or serious burns

Stop use and ask a doctor if infection occurs or if redness, irritation, swelling, or pain persists or increases

Directions

Apply locally as need

Other information

Inactive Ingredient

Glycerin, Propylene Glycol, PEG 1450, Sodium Hydrogen Phosphate, Citric Acid, Water

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TM TITUS MEDICAL POVIDONE IODINE 
povidone-iodine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81526-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81526-002-01100 in 1 BOX06/21/2021
11 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00306/21/2021
Labeler - Titus Medical LLC (080306309)
Registrant - Titus Medical LLC (080306309)
Establishment
NameAddressID/FEIBusiness Operations
Lights Medical Manufacture Co., Ltd.529128649manufacture(81526-002)

Revised: 11/2023
Document Id: 0b515218-f4a6-0b9c-e063-6294a90a337d
Set id: af7840c0-239e-4ff6-8d27-614e7d71ca99
Version: 4
Effective Time: 20231129
 
Titus Medical LLC