Povidone Iodine .1 mg/mL
Povidone Iodine · SWAB · Jianerkang Medical Co., Ltd
Povidone Iodine is a swab containing povidone iodine at .1 mg/mL, taken topical. Manufactured by Jianerkang Medical Co., Ltd.
Key Facts
- Brand Name
- Povidone Iodine
- Generic Name
- Povidone Iodine
- NDC Code (Product)
34645-1043- Manufacturer
- Jianerkang Medical Co., Ltd
- Strength
- .1 mg/mL
- Dosage Form
- SWAB
- Route
- TOPICAL
- Marketing Status
- Application #
- 505G(a)(3)
- Drug Class
- Antiseptic [EPC]
- Marketing Start
- 06/11/2015
Recall History
Zhejiang Jingwei Pharmaceutical Co., Ltd.
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.
CareFusion 213, LLC
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Degasa Sa De Cv
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Edge Pharma, LLC
Lack of Assurance of Sterility
Medline Industries Inc
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
Professional Disposables International, Inc
SubPotent: Out of Specification
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
Professional Disposables International, Inc
SubPotent: Out of Specification
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use Antiseptic skin preparation
Dosage & Administration
Directions Apply locally as needed.
Warnings
Warnings For external use only. Do not use if allergic to iodine Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burn Stop use and ask a doctor if infection occurs or if redness, irritation, swelling or pain persists or increases Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center Immediately Avoid excessive heat. Store at room temperature.
Frequently Asked Questions
What is Povidone Iodine used for?
Povidone Iodine contains Povidone Iodine. It is a swab taken topical. Consult your doctor for specific uses.
Is Povidone Iodine a controlled substance?
Povidone Iodine is not classified as a controlled substance by the DEA.
What is the generic name for Povidone Iodine?
The generic name for Povidone Iodine is Povidone Iodine. There are 10 other brand versions of Povidone Iodine.
What is the NDC code for Povidone Iodine .1 mg/mL?
The NDC (National Drug Code) for Povidone Iodine .1 mg/mL is 34645-1043, listed by Jianerkang Medical Co., Ltd.
Other Povidone Iodine Dosages
Other Povidone Brands
See all →- POVIDONE-IODINE PAD- povidone-iodine swab10 g/100g82098-617
- Povidone-Iodine Swabstick10 mg/mL10819-3800
- Povidone Iodine Impregnated7.5 mg/mL34645-4020
- DDM Povidone Iodine100 mg/mL53943-325
- Povidone Iodine Prep10 g/100mL68786-010
- Povidone Iodine Gel Swabstick10 mg/mL68786-418
- CVS Povidone Iodine10 mg/mL69842-935
- Povidone Iodine 10%100 mg/mL85786-702
- povidone iodine100 mg/mL0904-1103
- Povidone Iodine Impregnated.1 mg/mL34645-1030
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)