Tm Titus Medical Antiseptic Non Sterile Solution
FDA Label NDC 81526-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Titus Medical Llc for the product Tm Titus Medical Antiseptic Non Sterile (NDC 81526-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose, use:, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Povidone-Iodine USP (10%)

Purpose

Antiseptic

Use:

Antiseptic skin preparation

Warnings

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

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

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

Dosage & Administration

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

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

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