By MedFoundationNC.org Editorial Team | Skin Tag Removal | Published April 22, 2026
Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Skin tags and other skin growths should be evaluated by a dermatologist before any removal attempt. MedFoundationNC.org is an independent editorial publication — not a medical practice, hospital, or healthcare provider.
38 Documented Injury Cases — What the FDA Data Reveals
In January 2023, researchers from the FDA's Division of Pharmacovigilance published a study in the Journal of Clinical and Aesthetic Dermatology analyzing injury cases associated with unapproved topical mole and skin tag removers. The study identified 38 cases of adverse events reported to the FDA and documented in consumer product reviews through October 2021. Twenty-eight of those cases occurred in 2021 alone — a sharp increase that correlated with the growing availability of these products online.
The injuries documented in the study were not minor. They included chemical burns, deep tissue pain, ulceration, and permanent scarring. Fourteen of the 38 cases involved facial injuries, including four adjacent to the eye. Some patients required antibiotics, hospital care, specialized wound management, and dermatological consultation about skin grafts.
The ingredient categories identified across the injury cases included concentrated salicylic acid, Sanguinaria canadensis (bloodroot), other botanical and homeopathic ingredients, and calcium oxide. Seven cases involved products that did not list their ingredients at all.
These 38 documented cases almost certainly underrepresent the actual scope of the problem. The study's authors noted that FDA adverse event reporting relies on voluntary submissions, and most consumers who experience complications from an over-the-counter product do not file a formal report.
The 2022 FDA Warning Letters — Amazon, Ariella Naturals, and Justified Laboratories
Seven months before the injury study was published, the FDA took direct enforcement action. In August 2022, the agency sent warning letters to three companies — Amazon.com, Ariella Naturals, and Justified Laboratories — for selling unapproved drug products marketed for mole and skin tag removal.
The FDA's position was unambiguous. The agency stated that there are no FDA-approved over-the-counter drug products for the removal of moles and skin tags. Products making claims about removing, eliminating, or treating moles and skin tags meet the legal definition of drugs under the Federal Food, Drug, and Cosmetic Act — and introducing unapproved drugs into interstate commerce is a violation of that act.
The FDA's consumer warning accompanying the letters stated that these products — often sold as ointments, gels, sticks, or liquids — may contain high concentrations of potentially dangerous substances, even when marketed as natural or organic. The agency specifically warned that these products may cause injuries and scarring that could jeopardize consumer health when used without consulting a healthcare professional.
Following the warning letters, Amazon removed products making skin tag and mole removal claims from its United States marketplace. However, similar products remain widely available through independent websites and international retailers.
Why Bloodroot Products Carry Elevated Risk
Sanguinaria canadensis — bloodroot — is the active ingredient in multiple skin tag removal serums currently marketed online, including Natura Pro Skin Tag Remover, DermaClear, and similar products. Bloodroot has a long history in traditional medicine, but that history includes a specific mechanism that makes its use for self-treatment of skin growths risky.
Bloodroot is classified as an escharotic agent. Escharotics work by chemically destroying tissue — they cause necrosis (cell death) in the tissue they contact, forming a thick scab called an eschar. This is the same mechanism used in “black salve” products, which have been the subject of repeated FDA warnings and multiple case reports of severe disfigurement.
The problem with escharotic agents applied by non-professionals is precision. A dermatologist performing cryotherapy or excision targets only the skin tag. An escharotic cream or serum applied at home does not distinguish between the skin tag tissue and the healthy tissue surrounding it. Published case reports in dermatological literature document significant tissue destruction, deep scarring, and keloid formation from bloodroot-containing products — outcomes that are cosmetically worse than the skin tag they were meant to address.
A 2012 review published in the journal Dermatitis — authored by researchers from the Minneapolis VA Medical Center and the University of Minnesota — documented that bloodroot-containing products were widely available online despite their potential for serious adverse effects. The authors emphasized that clinicians should be aware of the risks and educate patients about treatment options before patients turn to unregulated products.
Bloodroot research is not entirely negative. Sanguinarine, the primary alkaloid in bloodroot, has been studied in laboratory settings for potential anticancer and antimicrobial properties. A 2025 study published in Biomolecules examined sanguinarine's effects on lung and colorectal cancer cell lines. But laboratory research on isolated compounds in controlled conditions is fundamentally different from applying a commercial topical product to your skin at home. The gap between laboratory findings and safe consumer use is where injuries happen.
Has the FDA Approved Any Skin Tag Remover?
No over-the-counter drug product has been FDA-approved for skin tag removal. This is worth repeating because the marketing of many skin tag removal products creates confusion on this point.
The phrase “manufactured in an FDA-approved facility” — which appears in marketing for multiple skin tag serums — refers to the manufacturing facility meeting general registration requirements. It does not mean the FDA has evaluated, reviewed, or approved the specific product for safety or efficacy. Cosmetic manufacturing facilities are required to register with the FDA. That registration does not constitute product approval.
What does exist in the regulatory environment is FDA-cleared cryotherapy devices. Products like Compound W Freeze Off, Claritag Advanced Skin Tag Remover, and Dr. Scholl's Freeze Away Skin Tag Remover have been reviewed through the FDA's 510(k) medical device clearance process. This process evaluates whether a device is substantially equivalent to a legally marketed predicate device and demonstrates a reasonable assurance of safety and effectiveness for its intended use.
The distinction matters. FDA-cleared cryotherapy devices have undergone a defined regulatory review process. Topical serums marketed as skin tag removers have not. They exist in a regulatory gap between cosmetics (which face minimal pre-market regulation) and drugs (which require FDA approval). Many of these products make claims that technically place them in the drug category — but they have not gone through the drug approval process.
How to Evaluate Any At-Home Skin Tag Product
If you are considering any at-home skin tag removal product, a systematic evaluation protects you. Before purchasing, verify these points.
First, determine the regulatory status. Is the product an FDA-cleared device (like a cryotherapy kit) or an unregulated topical serum? This single question separates products that have been through safety review from those that have not.
Second, examine the active ingredients. If the product contains Sanguinaria canadensis (bloodroot), sanguinarine, or is described as a “black salve” formulation, the escharotic mechanism carries documented tissue-destruction risk. If it contains concentrated salicylic acid above standard OTC concentrations, the FDA's wart remover monograph specifically warns against use on moles and birthmarks.
Third, check for third-party review verification. Is the product sold through major retailers with verified purchase reviews (Amazon, Walmart, pharmacy chains), or only through its own website? Products sold exclusively through their own websites have no independent review verification — every testimonial you see has been curated by the company.
Fourth, read the terms of service and refund policy before purchasing. Some skin tag removal products sold through independent websites use subscription billing models, mandatory arbitration clauses, and class action waivers that significantly limit consumer recourse if something goes wrong.
For a detailed evaluation of one of the most-searched products in this category, including ingredient analysis, regulatory context, consumer complaint patterns, and comparison to FDA-cleared alternatives, see our clinical analysis of Natura Pro Skin Tag Remover.
What FDA-Cleared Alternatives Look Like
FDA-cleared cryotherapy devices use controlled freezing to destroy skin tag tissue. The mechanism is targeted: the device applies extreme cold (typically using dimethyl ether and propane mixtures) directly to the skin tag, causing cellular destruction in the treated area. The skin tag typically detaches within 7 to 14 days as the frozen tissue dies and separates naturally.
These devices carry their own limitations. They may not achieve the extreme cold temperatures (-196°C) used in dermatological office cryotherapy with liquid nitrogen, which means they may be less effective on larger or more resistant skin tags. Application precision depends on the user — a device applied improperly can freeze surrounding healthy tissue, causing blistering or temporary discoloration. And they are specifically designed for skin tags only, not moles, warts, or other growths.
Despite these limitations, FDA-cleared cryotherapy devices represent the only at-home skin tag removal approach that has undergone defined regulatory safety review. For readers comparing these devices against topical serums, professional dermatological options, and home remedies, our complete method comparison breaks down the safety profile, effectiveness evidence, cost, and timeline for each approach.
The Professional Removal Standard
Dermatological removal remains the safest option by a wide margin. A dermatologist can confirm the growth is actually a benign skin tag (ruling out conditions that mimic skin tags), select the appropriate removal method for the size and location, and perform the procedure with precision instruments in a sterile environment. Most in-office skin tag removals take under five minutes and involve minimal discomfort.
Professional removal also addresses the diagnostic concern that at-home products cannot. A growth you assume is a harmless skin tag could, in uncommon cases, be a melanocytic lesion, neurofibroma, or other condition that requires biopsy rather than cosmetic removal. Self-treating without a professional evaluation bypasses the diagnostic step — and the FDA's 2022 consumer warning specifically cited delayed cancer diagnosis as a safety concern with at-home mole and skin tag removal products.
For readers whose skin tags recur after removal, understanding the metabolic and mechanical drivers behind recurrence — and what to do about them — is covered in our guide on why skin tags keep coming back. For a clinical explanation of what causes skin tags to form in the first place — including the insulin resistance pathway most people miss — our education guide covers the biology. And for those taking medications who need to know whether removal methods interact with their prescriptions, our medication interaction safety guide covers the considerations class by class.
This content was independently prepared by the MedFoundationNC.org Editorial Team based on published FDA data, peer-reviewed research, and regulatory documentation. It does not constitute medical advice or product endorsement. MedFoundationNC.org is an independent editorial publication — not a medical practice, hospital, or healthcare provider.