Henry Schein Povidone-iodine Prep Pad Swab
FDA Label NDC 0404-0121

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein, Inc. for the product Henry Schein Povidone-iodine Prep Pad (NDC 0404-0121). 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 in the eyes., otc - keep out of reach of children, directions, other 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

For preparation of the skin prior to surgery

Warnings

For external use only.

Do not apply to persons allergic to iodine.

Do Not Use In The Eyes.

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

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children
  • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Directions

Clean area. Apply to the operative site prior to surgery

Other Information

  • 1 % titratable iodine. Store at ambient temperatures

Inactive Ingredients

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Principal Display Panel - 0.5 Ml Item Label

NDC 0404-0121-01

HENRY SCHEIN ®

REF 570-1543

POVIDONE-IODINE
PREP PAD

10% Povidone-Iodine

For Professional and Hospital Use

Not Made with Natural Rubber Latex

HENRY SCHEIN
SEAL OF EXCELLENCE ®

1/Pouch

Principal Display Panel (0.5 mL Item Label)

Principal Display Panel (0.5 mL Item Label)

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