Initial availability of ZymaDerm at CVS and Walgreens
For many years, the homeopathic topical remedy ZymaDerm was widely available as an over-the-counter (OTC) product in major pharmacies. Older news releases from the manufacturer, Naturopathix Inc., indicated that ZymaDerm had secured distribution deals with large retailers like CVS and Walgreens. At the time, the product was marketed as a painless treatment for molluscum contagiosum. Online platforms like Instacart and Uber Eats also showed delivery options for ZymaDerm from CVS locations. This widespread availability positioned ZymaDerm as a common option for parents and adults seeking to address the viral skin infection.
The FDA warning against ZymaDerm
In a significant development, the FDA issued a warning letter to ZymaDerm's manufacturer in August 2023. This letter stated that the product was an unapproved new drug and could not be legally introduced into interstate commerce. The FDA noted that molluscum contagiosum is a condition that requires diagnosis by a healthcare professional, and there are no legally marketed OTC drug products for it. The FDA's concerns were magnified by the fact that ZymaDerm was promoted for use in children, potentially delaying a proper diagnosis and treatment for more serious conditions. This regulatory action fundamentally changed the product's status and its future availability through major retailers like CVS.
The nature of homeopathic drugs
While some homeopathic products may be sold without FDA approval under certain circumstances, the FDA's December 2022 guidance outlines how it intends to prioritize enforcement actions. The ZymaDerm product, which contains both homeopathic and non-homeopathic ingredients and makes specific treatment claims, falls into a higher-risk category that the FDA prioritizes for action. This regulatory shift emphasizes the importance of using only clinically proven and FDA-approved treatments for medical conditions like molluscum contagiosum.
Active ingredients and formula
ZymaDerm's formula includes a blend of ingredients, primarily homeopathic, along with essential oils.
- Homeopathic Active Ingredients:
- Argentum nitricum (Silver nitrate)
- Echinacea agustifolia
- Fucus vesiculosus
- Thuja occidentalis
- Other ingredients:
- Tea tree oil
- Clove oil
- Fractionated coconut oil
- Canola oil
Approved treatments for molluscum contagiosum
Because molluscum contagiosum requires professional diagnosis, the most effective and safest treatments are those recommended or administered by a healthcare provider. CVS itself provides information on several clinically sound alternatives to unapproved products like ZymaDerm.
- Ycanth (Cantharidin): Approved by the FDA in July 2023, Ycanth is the first FDA-approved treatment specifically for molluscum contagiosum in adults and children aged 2 years and older. It must be applied by a healthcare provider.
- Other Prescription Topical Agents: Dermatologists may prescribe other topical medications, such as imiquimod or tretinoin, depending on the patient's age and condition.
- Surgical Removal: For some cases, a provider may recommend physical removal techniques, including curettage (scraping), cryotherapy (freezing), or laser therapy.
ZymaDerm vs. FDA-approved options: A comparison
| Feature | ZymaDerm (Unapproved) | Ycanth (Cantharidin) (FDA-Approved) | Salicylic Acid (Off-Label OTC) |
|---|---|---|---|
| FDA Status | Unapproved New Drug; FDA issued warning. | FDA-approved in July 2023 for molluscum. | Approved for other conditions (e.g., warts); used off-label. |
| Regulatory Risk | High; subject to FDA enforcement action. | Low; meets FDA safety and efficacy standards. | None if used for approved purpose; not specifically for molluscum. |
| Mechanism | Homeopathic formulation with essential oils. | Causes blistering to remove the molluscum lesions. | Exfoliates the skin, but not a primary molluscum treatment. |
| Administration | Applied topically at home via applicator. | Administered in-office by a healthcare provider. | Applied topically at home. |
| Efficacy | Manufacturer claims 84% success rate in some studies, but this is not FDA-validated. | Clinically proven to clear molluscum bumps. | Variable; considered less reliable for molluscum. |
| Safety | Considered relatively gentle, but risks include delaying proper treatment. | Common side effects include blistering and pain at application site. | Generally safe but can cause skin irritation. |
What to do if you have molluscum contagiosum
The FDA's warning makes it clear that molluscum contagiosum should be handled with professional medical advice. Following these steps can help ensure a safe and effective treatment path:
- Consult a Healthcare Provider: See a doctor or dermatologist for an accurate diagnosis. They can confirm the condition and rule out more serious issues like skin cancer.
- Discuss FDA-Approved Treatments: Talk to your doctor about FDA-approved options like Ycanth (Cantharidin) for safe and effective lesion removal.
- Avoid Unapproved Products: Do not use homeopathic or other products that lack FDA approval for treating molluscum, as they may be ineffective or delay proper care.
- Explore CVS Resources: While ZymaDerm is no longer recommended, the CVS website provides a helpful resource on molluscum contagiosum and discusses professionally administered treatments.
Conclusion: Prioritizing safe and effective treatments
While older reports may suggest that CVS used to carry ZymaDerm, recent FDA regulatory action has significantly altered its status as an unapproved new drug. The FDA has warned against its use due to the potential for delaying proper medical diagnosis and treatment for molluscum contagiosum. Patients, particularly parents of young children, should consult a healthcare provider for an accurate diagnosis and to discuss clinically proven, FDA-approved treatment options. Relying on unapproved homeopathic remedies is not recommended and carries regulatory risks. For those seeking treatment for molluscum, the most prudent course of action is to seek professional medical advice and consider the FDA-approved and professionally administered therapies available.
