Povidone-iodine

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

42 more strengths and forms are listed in the FDA NDC Directory.

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

• Jianerkang Medical Co., Ltd26 products
• Changzhou Maokang Medical Products Co., Ltd26 products
• O&m Halyard, Inc.11 products
• Dukal LLC9 products
• Medline Industries, LP9 products
• Lights Medical Manufacture Co., Ltd.8 products
• Aplicare Products LLC7 products
• Professional Disposables International, Inc.6 products
• Atlantis Consumer Healthcare, Inc.6 products
• Cardinal Health 200, Inc5 products
• Sion Biotext Medical Ltd5 products
• Humco Holding Group, Inc.5 products
• Dynarex Corporation5 products
• Cardinal Health 200 LLC4 products
• Yiwu Ori-Power Medtech Co., Ltd.3 products
• Xinxiang Xinda Technology Co., Ltd3 products
• TwinMed LLC3 products
• Shield Line LLC3 products
• Degasa SA De CV3 products
• Pharma Nobis, LLC3 products
• Click Industries LLC3 products
• Henry Schein, Inc.3 products
• Acme United Corporation3 products
• Titus Medical LLC2 products
• Tupelo Brittany LLC2 products
• H E B2 products
• Changzhou Maokang Medical Products Co2 products
• Mazza Healthcare, LLC2 products
• Everlit Global Inc.2 products
• Phoenix Healthcare Solutions, LLC2 products

Showing the 30 companies with the most products, of 86.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

1. July 15, 2026 · Class III · Ongoing · D-0713-2026

   Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

   Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01. — Asclemed USA Inc.

2. June 4, 2026 · Class II · Ongoing · D-0627-2026

   sub potency

   Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. — Elevate Oral Care

3. May 18, 2026 · Class III · Ongoing · D-0552-2026

   Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

   Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 — Eugia US LLC

4. August 19, 2025 · Class III · Ongoing · D-0674-2025

   Subpotent drug

   READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25 — Medline Industries, LP

5. September 11, 2024 · Class II · Ongoing · D-0013-2025

   Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

   First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536- — Zhejiang Jingwei Pharmaceutical Co., Ltd.

6. August 26, 2021 · Class II · Terminated · D-0828-2021

   Subpotent Drug

   Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03 — AVRIO HEALTH L.P

7. July 23, 2021 · Class II · Terminated · D-0759-2021

   SubPotent: Out of Specification

   PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154 — Professional Disposables International, Inc

8. July 23, 2021 · Class II · Terminated · D-0758-2021

   SubPotent: Out of Specification

   PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1, — Professional Disposables International, Inc

9. July 23, 2021 · Class II · Terminated · D-0760-2021

   SubPotent: Out of Specification

   PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178. — Professional Disposables International, Inc

10. July 23, 2021 · Class II · Terminated · D-0761-2021

    SubPotent: Out of Specification

    PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185 — Professional Disposables International, Inc

11. November 11, 2019 · Class II · Terminated · D-0573-2020

    Presence of Foreign Substance: Foreign material found inside the vial.

    Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ — AuroMedics Pharma LLC

12. March 28, 2019 · Class I · Terminated · D-1248-2019

    Presence of Particulate Matter: One vial was found to contain a hair.

    Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05 — Aurobindo Pharma USA Inc.

13. February 15, 2018 · Class II · Terminated · D-0546-2018

    Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.

    PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04 — Medline Industries Inc

14. October 5, 2017 · Class II · Terminated · D-0070-2018

    Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.

    Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01 — Purdue Pharma, LP

Sources

1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

Report an error → · Information for medicine makers