Is your Pain Relief Cream FDA Registered?

I am amazed by the number of “pain relief” creams in the market. There must be thousands of them and most people that sell these creams are in it to make a quick buck. They put a bunch of alcohol, some cheap ingredients, a little menthol/camphor, throw on a label and sell it. One of the most frustrating things for legitimate pain relief brands is competing with sellers because it makes it really hard to build trust with customers after they have been let down so many times. In this blog post, I want to share with you why it’s so important for your pain relief cream to be FDA Registered. 

What is an FDA Registered Pain Relief Cream?

The Food and Drug Administration is a government agency that is responsible for protecting the public by ensuring that products like pain relief creams are safe and effective. There are several classifications that a product can have, but for the purposes of this article we will discuss the top 3. 

FDA Approved

This is the highest level of clearance that a product can have and it requires years of research and clinical studies. This classification is for prescription drugs and medical devices.

FDA Registered

This next level is for products like Over The Counter (OTC) pain relief creams, sunscreens, and acne face creams because they have active ingredients and actually help to alleviate bodily conditions. These products are required to be registered in the FDA database and their manufacturing practices are audited. Manufacturers must conduct special testing of the products, keep detailed records, and their facility needs to be certified with the FDA to produce OTC products. 

Cosmetics

There is no requirement for cosmetic products because they do not contain active ingredients and should not make claims to help alleviate a condition. These products are things like lipsticks, body lotions, etc. There is minimum oversight by the FDA in this group.

How do some pain relief products get away without being FDA Registered?

Some of the most popular products that the public believe are Pain Relief Creams are in fact not pain relief creams and are actually Cosmetics. They do this by naming their products as “muscle soother”, “therapy lotion”, “anti-inflammatory formulation” and other vague names, but if you notice closely they do not say Pain Relief on their packaging. Many do put pain relief claims on their websites because if they are reported to the FDA, they can quickly change text on a website and ask for forgiveness. 

If you notice the labels on our Aromalief Creams, our front label says Pain Relief and our back label has the "Drug Facts" in the required format from the FDA. Products that are FDA Registered Over The Counter must have a Drug Facts Label.

Why are “Pain Relief” Creams not FDA Registered?

Companies prefer to be categorized as Cosmetics because it is cheaper and less labor intensive. Getting a manufacturer license from the FDA to make OTC products is a more complex process and paying for additional lab testing and documentation is not something they want to deal with. 

Why is buying FDA Registered Pain Relief Creams good for you?

When you buy a pain relief cream that is FDA Registered, you know that the product has been tested for safety and efficacy at a higher level. Even though you are not ingesting the product, it is going on your skin and you want to make sure that it is safe for you to use. You only have one body and it’s important to take care of it. You also want to know that the active ingredients in the product are in the percentage that the company says they are in and that they are actually active prior to expiration, so that you don’t throw away your money in “magic potions”. 

How do I know if my pain relief cream is FDA Registered?

The first sign is to look for a drug facts panel on the jar, box, tube, or packaging it comes in. Then you can go to a website called DailyMed to look up the product by brand or product name. This is the link to the Aromalief Lavender Creams FDA registration for example. There needs to be a registry for each product and each is give an NDC (National Drug Code)

Your safety is our number 1 concern and we do everything possible to follow the law to provide you with safe and effective pain relief creams.

Aromalief® is a brand of topical pain relievers made in USA for women with chronic pain by women. It is 97% Naturally-derived, Vegan, and Cruelty-Free.