Povidone-iodine
FDA Label NDC 35617-397

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nantong Strip Medical Supply Co.,ltd. for the product Povidone-iodine (NDC 35617-397). 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 use, purpose, cautions, otc - keep out of reach of children, directions, other information, active ingredient, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Use

Antiseptic for preparation of skin.

Purpose

Antiseptic

Cautions

For External Use Only.Do not use:Apply over large areas of the body, use in the eyesDrug Facts (continued):Stop use and ask a doctor if irritation and redness develops. If condition persists for more than 72 hours, consult a physician.

Otc - Keep Out Of Reach Of Children

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

Directions

Wipe injection site vigorously and discard.

Other Information

Store at room temperature, 59°-86°F(15°-30℃), avoid excessive heat.

Active Ingredient

Povidone Iodine 10% w/v (equivalent to 1%iodine)

Inactive Ingredients

Water

Package Label.Principal Display Panel

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397 (Povidoneiodineswabsticks)

397 (Povidoneiodineswabsticks)

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