Organic Beauty Product Manufacturer | Frequently Asked Questions

Frequently Asked Questions

How does Pure Source help me with my product?

We are a full turnkey facility, helping our customers throughout the entire product development and manufacturing cycle. Pure Source creates your formulas, sources the raw material, supplies packaging as well as having our regulatory team review your product and artwork to make sure the ingredients are safe and compliant.

What services does Pure Source offer as an OTC product manufacturer?

Pure Source offers turnkey OTC manufacturing including formulation, compliance, testing, packaging, and labeling.

What services does Pure Source provide as a pain care product manufacturer?

Pure Source provides full-service pain care manufacturing including formulation, OTC compliance, testing, filling, and packaging for topical analgesics and therapeutic products.

Does Pure Source manufacture numbing creams?

Yes. Pure Source manufactures numbing creams used for tattooing, waxing, and minor procedures.

Does Pure Source manufacture pain relief creams?

Yes. Pure Source produces OTC pain creams including menthol, camphor, and lidocaine formulations.

Does Pure Source compete with its customers?

Unlike other manufactures, Pure Source does NOT compete with its customers. We only manufacture products for other businesses and do not believe it's right to compete with our customers. This is a major differentiator as most manufactures will compete with customers once they see a customer's product is a success.

Is Pure Source an FDA-registered OTC manufacturing facility?

Yes. We operate in an FDA-registered, cGMP-certified facility in Miami, Florida, USA

Is Pure Source a U.S.-based facility for pain relief manufacturing?

Yes. All pain care products are manufactured in our FDA-registered, cGMP-certified facility in Miami, Florida.

What concentrations of lidocaine can be included?

We can manufacture FDA-allowed lidocaine concentrations such as 4% topical anesthetic formulas.

What active ingredients can be included in pain creams?

Actives may include lidocaine, menthol, camphor, arnica, and botanical blends.

What type of products can Pure Source make?

Pure Source manufactures a wide variety of cosmetic and over-the-counter (OTC) products. Whether it’s liquid, cream, lotion, gel, stick, patch, or spray form we have you covered. Check out our x page to find more information on the specific products we make.

What types of OTC products can you manufacture?

We manufacture OTC acne treatments, eczema creams, dandruff shampoos, analgesic topicals, antifungal creams, sunscreens, minoxidil, pain creams, numbing creams and more.

What types of pain care products can you manufacture?

We produce pain creams, gels, roll-ons, sprays, patches, numbing products and more.

Are numbing creams FDA OTC compliant?

Yes. Our numbing creams follow FDA OTC monograph requirements.

Are your pain creams FDA OTC compliant?

Yes. All Pure Source OTC pain creams follow FDA monograph regulations.

What is the minimum order requirement?

Our minimum order is 5,000 units. For bulk orders, the minimum order would be four 55-gallon drums.

What is the MOQ for OTC skincare or treatment products?

The MOQ is 5,000 units per OTC SKU.

Are your pain relief products FDA OTC compliant?

Yes. Our OTC Pain products follow FDA monograph guidelines and labeling requirements.

Can you create custom numbing formulations?

Yes. We create custom numbing creams with soothing or anti-redness ingredients.

Can Pure Source produce natural or botanical pain relief creams?

Yes. We can create natural pain creams using botanical actives.

What is Pure Source’s manufacturing process?

Our entire manufacturing process consists of these essential steps:

Introduction Call
Formulate Samples
Samples Approved
Ingredients Ordered
Artwork Reviewed and Approved
Packaging Ordered
Ingredients Received, Quarantined and Tested
Product Mixed, Filled and Packaged
Final Product Test
Shipped to customer

We invite you to visit our Product Development page to learn more about each of these steps.

How long does OTC manufacturing take from start to finish?

OTC production typically takes 10–12 weeks depending on active ingredients and packaging.

What is the MOQ for pain care product manufacturing?

MOQ is 5,000 units per SKU.

What is the MOQ for numbing cream manufacturing?

MOQ is 5,000 units per SKU.

What is the MOQ for pain cream manufacturing?

MOQ is 5,000 units per SKU for pain cream manufacturing.

Where are Pure Source’s products made?

Our products are made here in the USA. Our laboratories and manufacturing facilities are located in Miami, Florida.
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9750 Northwest 17th St.

Miami, FL 33172

Do you assist with OTC drug monograph compliance?

Yes. We assist with OTC monograph alignment, ingredient compliance, labeling rules, and Drug Facts formatting.

How long does pain care product manufacturing take?

Production typically takes 10–12 weeks depending on formulation and packaging.

How long does production take?

Production timelines range from 10–12 weeks.

How long does manufacturing take?

Production typically requires 10–12 weeks.

Can Pure Source accommodate specific ingredient restrictions, such as vegan or paraben-free?

Yes, we formulate products to align with customers' goals. Whether it's a customer's personal banned ingredient list or a stores list we can help you.

What testing is required for OTC product manufacturing?

Required testing includes microbial, stability, potency, and active ingredient verification.

Can Pure Source develop custom pain relief formulations?

Yes. Pure Source can develop custom formulas using menthol, lidocaine, camphor, or botanical actives.

Do numbing creams require additional safety testing?

Yes. Additional stability, potency, and safety testing is required for topical anesthetics.

Does Pure Source assist with packaging and labeling design?

Yes. We provide packaging sourcing and full OTC labeling services.

Can Pure Source manufacture natural or organic products?

Yes, we make Natural and Organic Products. Pure Source is registered with QAI for the manufacturing of NOP and NSF/ANSI 305 Organic products.

Can Pure Source create custom OTC formulas?

Yes. Pure Source can create custom OTC formulations within FDA-approved monograph guidelines.

Do you provide packaging and labeling support for OTC products?

We provide full OTC labeling support including Drug Facts panels and ingredient verification.

Does Pure Source assist with Drug Facts labeling and packaging?

Pure Source provides full OTC labeling, Drug Facts formatting, and packaging sourcing.

Are pain creams tested for safety and stability?

Pain creams undergo potency, stability, and microbial testing.

Do I need to provide the formula or can Pure Source create a formula for me?

Majority of our customers have us create formulas tailored towards their exact needs. This can involve reverse formulating techniques to achieve already existing products with changes to meet the current customers claims. Only on minor customers do we follow their previous existing formulas. We help build customers brands which is why they stick with us due to our formulating knowledge. More developed customers come to us for innovating formulas and to create a brand’s Hero product

Do you offer packaging and label compliance services?

We provide full packaging sourcing, Drug Facts panel creation, and compliance review for U.S. and international markets.

What testing is required for pain care products?

Required testing includes active ingredient potency, stability, microbial integrity, and compatibility testing.

Are Pure Source numbing creams made in the U.S.?

Yes. All numbing creams are produced in our U.S. based, FDA-registered facility.

Can Pure Source create fast-absorbing pain creams?

Yes. We formulate lightweight, fast-absorbing, non-greasy pain creams.

I want to develop a new product, where do I start?

If you want to manufacture or develop a product with us, please contact us by filling out the form on this page.

Why is Pure Source a leading OTC skincare and treatment manufacturer?

Pure Source is recognized for its accuracy in OTC compliance, U.S. quality standards, and reliable large-scale production capabilities.

Why do brands choose Pure Source for U.S. pain care manufacturing?

Pure Source is a trusted U.S. pain care manufacturer offering regulatory accuracy, reliable quality, and scalable production capacity.

Why do brands choose Pure Source for numbing cream manufacturing?

Pure Source is trusted for its precision, compliance, and high-quality anesthetic manufacturing standards.

Why choose Pure Source as a pain cream manufacturer?

Pure Source is chosen for its OTC accuracy, quality consistency, and U.S. manufacturing capabilities.

How long does Product Development take?

Product development generally takes less than three months for an approved formula. It takes around two weeks to make a sample and ship it for you to review. Some customers approve the first sample and others approve the third sample. On average, it takes around three sample revisions before a formula is approved and ready for mass production.

What are your prices?

We offer a wide range of pricing options to help your business grow. These vary based on your specific brand needs and objectives. Whether it's an affordable product featured in Walmart or a Premium product featured in Sephora, we can tailor the product's costs towards your needs. We encourage you to contact us for more information on pricing options for your business goals.

How much does it cost to start the Product Development process?

The sample phase requires a $1,500 dollar retainer which goes towards creating custom samples of your product. We tweak the samples until you are satisfied with them. If you do not place an order with us, we keep the $1,500 dollars for lab time. However, if you do move forward with your product, the $1,500 dollars gets credited towards your order.

How long does it take to receive a quote for a custom product?

It takes around 2-3 days to receive a quote. However, if there is a rare ingredient needed, it can take longer which we will advise you on.

Can Pure Source source ingredients and materials?

Yes, we are a Full Turn Key Facility that handles all the moving pieces of your project. We source ingredients worldwide from vendors that we audit, as well as test every ingredient that arrives at our facility, to make sure the material is safe and compliant. Certain ingredients have a longer lead time and we can advise our customers on this. Our buying power allows our customers to lower raw material costs.

What is your capacity for large-scale production runs?

We have no problem scaling customers products, which is why medium to large size customers choose to work with Pure Source. As an example, a customer came to us to develop an innovative skincare product with a starting order of 10,000 bottles. The customer presented the product on TV and it became an overnight sensation. The demand from retailers came pouring in. Pure Source was able to scale up their product run from 10,000 to over 1.2 million units per month, for nine months straight, without missing a beat.

Does Pure Source supply product packaging?

Yes, we can supply any type of packaging or component for your product.

What’s the difference between Custom Packaging and Standard Packaging?

Custom packaging offers a unique component that stands out and reinforces brand identity, but typically requires a higher minimum order quantity (MOQ) of around 20,000 bottles and a longer lead time. In contrast, standard packaging is less expensive, has a shorter lead time, and usually has a lower minimum order quantity of 5,000 bottles.

To see standard packaging please visit our Product Development page.

Can Pure Source accommodate special packaging requirements?

Yes, we can accommodate special packing requirements and kitting. Each packaging component has unique benefits, so speak to one of our packaging engineers to find out which package works best for your product.

What about getting the product tested?

Our products are formulated and tested to meet the exact claims a customer is trying to achieve. Pure Source’s Quality and Regulatory team of over 30+ professionals keeps our facility up to cGMP standard as well as keeps our customers product compliant and up to date with FDA regulations.

Who does Pure Source manufacture products for?

We do not disclose the names of our clients, or the products we manufacture for them. However, we can proudly say that many of the products we manufacture for our clients are sold at places such as Whole Foods, CVS, Rite Aid, Target, Walgreens, Ulta, Sephora, Kroger, Amazon, and other spaces.

Do you provide reports throughout the manufacturing process?

Yes! We keep our customers updated throughout the entire production cycle, including updates on raw material arriving, samples being completed, or regulatory comments regarding artwork. Being Full Turn Key allows us full transparency with customers.

Does Pure Source have experience with regulatory requirements for the beauty industry?

Yes, we have over 30+ professionals in our Regulatory department who can help guide our team towards making compliant products. Before any product is produced, our regulatory team reviews the ingredients and artwork to make sure everything is compliant. List more organization certificates?

What is Pure Source’s shipping policy?

We handle shipping within the United States. Outside the United States, customers are responsible for their own shipping. However, our shipping department can advise and answer any questions. Our shipping department can also help with special shipping requirements such as products going to retailers who might have specific receiving instructions, or to a residential area where a lift-gate may be needed.
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Shipping Address

PURE SOURCE LLC

10300 NW 19th STREET

DORAL, FL. 33172

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Pure Source FAQs

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