FDA Warns Against Painless Tattoo Numbing Cream: What You Need to Know

The quest for painless tattoos has led to a surge in the popularity of tattoo numbing creams. These topical anesthetics promise to take the edge off the needle, making longer and more intricate tattoo sessions bearable. Among these products, Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray have gained attention. However, a recent warning letter from the U.S. Food and Drug Administration (FDA) has cast a shadow over these products, raising serious concerns about their safety and legality. This article breaks down the FDA’s warning, explains what it means for tattoo enthusiasts, and explores the crucial aspects you need to consider when thinking about using numbing creams for your next tattoo.

Unpacking the FDA Warning Letter

On March 25, 2024, the FDA issued a formal warning to Sky Bank Media, LLC, the company behind Painless Tattoo Numbing Cream Co., regarding their Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray. The FDA’s letter, referencing product investigation number 3028005436, states that after reviewing the company’s website and product labeling in November 2023, they determined these products are in violation of federal law. The core issue? The FDA classifies these numbing products as unapproved new drugs and misbranded drugs. This isn’t just a slap on the wrist; these are serious regulatory violations with potential consequences for both the company and consumers.

Key Violations Highlighted by the FDA

The FDA’s warning letter meticulously details several key violations:

Unapproved New Drugs: According to the FDA, Painless Tattoo Numbing Cream and Spray are considered “drugs” under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended to affect the structure or function of the body by providing pain relief. To legally market a new drug, companies must obtain FDA approval, which typically involves rigorous testing and demonstration of safety and effectiveness. Painless Tattoo Numbing Cream Co. has not obtained this required approval.
Misbranded Drugs: The products are also deemed “misbranded” because they do not comply with the requirements for over-the-counter (OTC) drugs marketed without approved applications, as outlined in section 505G of the FD&C Act. This section governs nonprescription drugs and sets standards for safety and labeling.
Exceeding Permissible Lidocaine Concentrations: A major point of concern is the concentration of lidocaine, a common anesthetic, in these products. The Painless Tattoo Numbing Cream and Spray are labeled to contain 5% lidocaine. However, the FDA’s Over-the-Counter Monograph M017 for external analgesic drug products (which sets the rules for OTC pain relief creams) only permits lidocaine concentrations between 0.5% and 4% for products marketed without FDA approval. The 5% concentration in Painless Tattoo Numbing Cream and Spray exceeds this limit.
Unapproved Combinations of Active Ingredients: Adding to the concern, these products contain combinations of active ingredients not allowed under the OTC monograph. Specifically, they list prilocaine and epinephrine as additional active ingredients alongside lidocaine. Neither prilocaine nor epinephrine are permitted active ingredients in the FDA’s monograph for OTC external analgesics.
Unsubstantiated and Unapproved Indications: The FDA also points out that the marketing claims for Painless Tattoo Numbing Cream and Spray extend beyond the approved uses for OTC external analgesics. Claims suggesting use for “tattoo removal, microblading, laser hair removal, permanent cosmetics, waxing, injections, piercings, lip fillers, blood tests, vaccinations,” and similar procedures are not within the scope of approved indications for OTC pain relief creams. The FDA emphasizes that using these products for cosmetic procedures, especially on broken or irritated skin, raises safety concerns due to potentially increased drug absorption.

Safety Concerns: Why the FDA is Worried

The FDA’s warning isn’t just about regulatory compliance; it’s rooted in genuine safety concerns. The letter highlights the potential dangers associated with using external analgesic drug products, especially those with high concentrations of active ingredients like lidocaine, in the context of cosmetic procedures.

Increased Absorption and Systemic Toxicity

The primary safety worry revolves around increased absorption of the active ingredients, particularly lidocaine, through the skin. When topical anesthetics are applied:

Over large areas of skin: As might be the case for larger tattoos.
On irritated or broken skin: Common during tattooing and other cosmetic procedures.
For prolonged periods: Often done to maximize numbing effect before and during long tattoo sessions.
When the skin is covered (occluded): As recommended in the directions for Painless Tattoo Numbing Cream, which advises wrapping the area with plastic wrap.

These factors can significantly increase the amount of lidocaine and other active ingredients that enter the bloodstream. Excessive absorption can lead to systemic toxicity, meaning the drug reaches harmful levels throughout the body.

Risks of Unsupervised Use

The FDA emphasizes that using these products before or during cosmetic procedures often occurs without the supervision of trained health professionals. This lack of professional oversight is a significant concern because:

Individuals may apply excessive amounts of numbing cream or spray, thinking more is better.
Users may not be aware of the risks of systemic absorption or the signs of toxicity.
There is no medical professional present to monitor for adverse reactions or provide immediate assistance if problems arise.

Public Health Advisories

The FDA has previously issued multiple public health advisories specifically warning about the dangers of using skin numbing products containing lidocaine and similar “-caine” type ingredients. These advisories caution against improper use, emphasizing the potential for serious injury and even life-threatening side effects when these products are misused or overused.

What This Means for Tattoo Lovers

The FDA’s warning letter to Painless Tattoo Numbing Cream Co. carries important implications for anyone considering using tattoo numbing creams:

Questionable Legality and Safety: The FDA has clearly stated that Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray are unapproved new drugs and misbranded. This raises serious questions about their legality and, more importantly, their safety for consumers.
Be Wary of High Lidocaine Concentrations: The FDA specifically flags the 5% lidocaine concentration as exceeding safe limits for OTC products. Be cautious of any tattoo numbing cream that boasts very high percentages of lidocaine or other active anesthetic ingredients. Higher concentration does not necessarily mean better pain relief and significantly increases the risk of adverse effects.
Unapproved Ingredient Combinations: The presence of prilocaine and epinephrine in these products, alongside lidocaine, is another red flag. These combinations are not approved for OTC use and may carry additional risks that are not fully understood.
Misleading Marketing Claims: Be skeptical of overly broad marketing claims that promise pain-free tattoos or suggest the product is safe for a wide range of cosmetic procedures beyond basic pain relief. The FDA highlights that many of these claimed uses are not supported and raise safety concerns.
Consult Professionals: If you are considering using a tattoo numbing cream, the safest approach is to consult with a healthcare professional or a dermatologist. They can provide personalized advice based on your health status, skin type, and the planned tattoo procedure. Discussing pain management options with your tattoo artist is also crucial; they may have recommendations or insights based on their experience and client needs.
Prioritize Safety over “Painless” Tattoos: While the desire for a painless tattoo experience is understandable, it’s essential to prioritize safety. Unregulated and potentially unsafe numbing products can pose significant health risks. Consider alternative pain management strategies, such as shorter tattoo sessions, breaks during longer sessions, and open communication with your artist about your pain tolerance.

Moving Forward: Informed Choices for Tattoo Pain Management

The FDA warning letter serves as a critical reminder that not all products marketed as “painless tattoo numbing cream” are created equal or safe. As a tattoo enthusiast, being informed and discerning is paramount.

Instead of blindly reaching for the strongest numbing cream available, take a more cautious and informed approach:

Research Ingredients: Understand the active ingredients in any numbing cream you consider. Lidocaine is generally considered safe at lower concentrations (as permitted in OTC monographs), but higher concentrations and combinations with other anesthetics require careful consideration and potentially professional guidance.
Check for FDA Compliance (Where Possible): While tattoo numbing creams may not always require pre-market FDA approval if they adhere to OTC monograph conditions, look for products from reputable brands that are transparent about their ingredients and manufacturing processes. Be wary of products with vague labeling or those making exaggerated safety claims.
Read Reviews and Seek Recommendations: Look for reviews from other tattoo recipients and, ideally, recommendations from trusted tattoo artists. However, remember that individual experiences can vary, and what works for one person may not be suitable or safe for another.
Consider Non-Numbing Pain Management: Explore non-topical pain management techniques like deep breathing exercises, meditation, or over-the-counter pain relievers (taken orally, as directed by a doctor or pharmacist) if appropriate for your situation.

Ultimately, the goal is to have a safe and positive tattoo experience. While numbing creams can be tempting, especially for those with low pain tolerance or for longer tattoo sessions, it’s crucial to approach them with caution, awareness, and a focus on your health and well-being. The FDA’s warning regarding Painless Tattoo Numbing Cream and Spray underscores the importance of making informed choices and prioritizing safety when it comes to tattoo pain management.