Key Takeaway

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Par by The Mentholatum Company was recalled on July 31, 2020. The hazard: Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box...

FDA Drug Class III Terminated

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Par

Recalled: July 31, 2020 ~31,732 Blister Packs units affected D-1541-2020

Description

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8

Hazard / Reason

Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Par

Drugs

Company Information

The Mentholatum Company

Orchard Park, NY, United States

View all 1 recalls by The Mentholatum Company →

Distribution

Nationwide within the U.S.

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Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

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