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FDARecalled Oct 23, 2024 · #D-0013-2025

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. Ma...

Hazard

Class II — temporary health risk

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Description

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. Classification: Class II Distribution: Distributed to one wholesaler in OH for Nationwide distribution.

Product details

Product
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
Type
Drugs
Manufacturer
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Model numbers
220901, 230701, 230301, 230401, 230501, 230801, 240301, 240501
UPCs