Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium Chloride and Benzocaine)

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01

Affected NDC 16864-0670-01

Compare with the code on your package — it is the most precise check available.

Drug: Benzocaine

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Dermoplast First Aid BENZETHONIUM CHLORIDE and BENZOCAINE NDC 16864-0670	BENZETHONIUM CHLORIDE 2 mg/g; BENZOCAINE 200 mg/g	Spray Topical	Advantice Health, LLC	OTC

Recalling firm: Advantice Health, Llc
NDC code: 16864-670-01
Origin: NJ, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0329-2023 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.