Sterile Solution
FDA Label NDC 83645-552

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Asia Dynamics Inc., D/b/a Adi Medical for the product Sterile (NDC 83645-552). 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, do not use, stop use and ask a doctor if, keep out of reach of children., ask a doctor before use if injuries are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Povidone-lodine USP 10%

Purpose

Antiseptic

Use

for antiseptic skin preparation

Warnings

For external use only

Avoid pooling beneath patient

Do Not Use

  • if allergic to lodine
  • in the eye

Stop Use And Ask A Doctor If

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

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 or puncture wounds
  • serious burns

Directions

apply locally as needed

Other Information

  • 1% titratable iodine
  • for hospital or professional use only

Inactive Ingredients:

Nonyl Nonoxynol-10, Glycerin, Purifed Water.

Package Labeling:

Label (552)

Label (552)

NDC 83645-552-11

ADI Medical

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