FDA.reportPublic FDA data

TM TITUS MEDICAL ANTISEPTIC Non Sterile

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 00:53:04

Label at a glance#

ProductTM TITUS MEDICAL ANTISEPTIC Non Sterile
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP (10%)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

Antiseptic skin preparation

WARNINGS SECTION

Warnings:

Do not use if allergic to iodine in eyes

For external use only

Avoid "pooling" beneath patients. 

Avoid excessive heat. Store at room temperature.

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

  • redness, irritation, swelling, or pain persists or increases
  • infection occurs

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

DOSAGE & ADMINISTRATION SECTION

Apply locally as need

OTHER SAFETY INFORMATION

Other information

  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Citric acid, Disodium phosphate, Nonoxynol-9, Sodium hydroxide, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
81526-001-01TM TITUS MEDICAL ANTISEPTIC Non Sterile30 mL in 1 POUCHSOLUTION305
81526-001-02TM TITUS MEDICAL ANTISEPTIC Non Sterile200 in 1 BOXSOLUTION2005
81526-001-02TM TITUS MEDICAL ANTISEPTIC Non Sterile30 mL in 1 POUCHSOLUTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81526-001TM TITUS MEDICAL ANTISEPTIC NON STERILE (POVIDONE-IODINE) SOLUTION [TITUS MEDICAL LLC]5Current NDC, Legacy NDC, 3 package rows20250119_690b87d0-d889-43c6-b99e-cd9f26fd682a.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
81526-00181526-001-01, 81526-001-02

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
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONE-IODINE85H0HZU99MACTIM

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 ANTISEPTIC Non SterilePOVIDONE-IODINETitus Medical LLC690b87d0-d889-43c6-b99e-cd9f26fd682a2025-01-17WarningsExact identifier
ndc (package): 81526-001-02
ndc (package): 81526-001-01
ndc (product): 81526-001
ndc11 (package): 81526000102
ndc11 (package): 81526000101
spl id: 2be13c4e-407d-70da-e063-6394a90aa19c
spl set id: 690b87d0-d889-43c6-b99e-cd9f26fd682a

Reported adverse events (FAERS/openFDA)#

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