The Recall Desk
ModerateFDA (Drugs)·D-0329-2023·Announced 2023-03-01

OTC First Aid Spray Recalled for Subpotent Active Ingredient

Dermoplast FIRST AID spray is being recalled because testing found low levels of one of its two active ingredients. The product was distributed nationwide through internet, distributors, and retailers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall based on low assay detected during stability testing. No acute hazards or illnesses reported. The subpotent formulation reduces product effectiveness but does not pose a direct health risk.

Plain-English summary

Advantice Health, LLC is recalling Dermoplast FIRST AID Antibacterial Spray (Lot #22336A, NDC 16864-670-01) because stability testing identified low assay in one of the product's two active ingredients: benzethonium chloride 0.2% (first aid antiseptic) or benzocaine 20% (topical analgesic).

The affected lot contains 16,152 cans distributed across 673 cases. The product was distributed nationwide through internet retailers, distributors, and retail stores.

The subpotent formulation means the product may have reduced effectiveness compared to the labeled specifications. Consumers should be aware of this limitation if they have purchased the recalled lot.

The recalled product

Product
DERMOPLAST FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE)
Brand
DERMOPLAST FIRST AID
Manufacturer
Advantice Health, Llc
Category
Drug — Topical First Aid
Hazard
  • subpotency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # 22336A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category