Povidone Iodine Impregnated Sponge
FDA Label NDC 34645-1032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jianerkang Medical Co., Ltd for the product Povidone Iodine Impregnated (NDC 34645-1032). 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 ingredients, purpose, uses, warnings, stop use and ask a doctor if, 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 Ingredients

Povidone Iodine, USP 7.5% (0.75% available Iodine)

Purpose

Antiseptic

Uses

For preparation of skin and mucous membranes prior to surgery

Warnings

For external use only

Avoid use on persons allergic to iodine

Stop Use And Ask A Doctor If

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep Out Of Reach Of Children

If swallowed, get medical help or contact Poison Control Center right away

Directions

open pouch at tear notch

use sponge sticks to prep desired area

Other Information

store at room temperature
avoid excessive heat (above 104 oF/40 oC)
protect from freezing
latex free

Inactive Ingredients

purified water, hydroxyethylcellulose, Nonylph

Package Label

L3 (Label3)

L3 (Label3)

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