FDA.reportPublic FDA data

TM Titus Medical Povidone Iodine

Manufacturer
Titus Medical LLC | Lights Medical Manufacture Co., Ltd.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:06

Label at a glance#

ProductTM Titus Medical Povidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Indications and uses

Antiseptic skin preparation

Dosage and administration

Apply locally as need

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP (10%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Antiseptic skin preparation

Warnings

WARNINGS SECTION

For external use only

Do not use if allergic to iodine in the eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ASK DOCTOR SECTION

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

DOSAGE & ADMINISTRATION SECTION

Apply locally as need

Other information

OTHER SAFETY INFORMATION

  • not made with natural rubber latex
  • for hospital or professional use only

Inactive Ingredient

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312563povidone-iodine 10 % Topical OintmentPSN5
312563povidone-iodine 0.1 MG/MG Topical OintmentSCD5
312563povidone-iodine 10 % (equal to 1 % available iodine) Topical OintmentSY5
312563povidone-iodine 10 % Topical OintmentSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81526-002-01TM Titus Medical Povidone Iodine100 in 1 BOXOINTMENT1005
81526-002-01TM Titus Medical Povidone Iodine1 g in 1 POUCHOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81526-002TM TITUS MEDICAL POVIDONE IODINE (POVIDONE-IODINE) OINTMENT [TITUS MEDICAL LLC]5Current NDC, Legacy NDC, 2 package rows20250119_af7840c0-239e-4ff6-8d27-614e7d71ca99.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81526-00281526-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TM Titus Medical Povidone IodinePOVIDONE-IODINETitus Medical LLCaf7840c0-239e-4ff6-8d27-614e7d71ca992025-01-17WarningsExact identifier
ndc (package): 81526-002-01
ndc (product): 81526-002
ndc11 (package): 81526000201
spl id: 2be150f0-1de0-7377-e063-6394a90a4f13
spl set id: af7840c0-239e-4ff6-8d27-614e7d71ca99

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.