FDA-Drug2024-10-23Class II
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: 0536-1271-80
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Hazard
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.
Sold states
Distributed to one wholesaler in OH for Nationwide distribution.
Affected count
295,164 tubes
Manufactured in
Wengjia Road, Changshan Industrial Park No.19, Quzhou, China
Products
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: 0536-1271-80
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2025Don't want to check this manually?
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