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An OTC (Over The Counter) Drug Monograph is a set of regulations that serve as a benchmark for determining the safety and effectiveness of over-the-counter (OTC) products. It includes detailed requirements such as active ingredients, labeling, and warning statements for each product category. Continuously updated, these regulations ensure that OTC products adhering to the monograph are considered safe and effective in the market.

View detailed FDA OTC Monograph site↗

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Have you ever seen a Drug Facts label on products sold in the United States?

In the U.S., OTC products are required to list active ingredients, usage instructions, and related information on a 'Drug Facts' label so that customers can easily understand them.

Adhering to the Drug Facts labeling regulations, which serve as the verification standard for OTC products, is very important. CTKCLIP guides you through this labeling process during product development to ensure it is not difficult.

[Label Information]

• Active Ingredients and Inactive Ingredients.
• Purpose: Indicate each active ingredient included in the product and its purpose.
• Use: Indicate the approved uses of the product; for OTC cosmetics, only uses with medicinal relevance are listed.
• Warning: There is no specific order for listing warnings, but it is recommended to list them in order of importance.
• Directions: Indicate information such as age restrictions, usage methods, and recommended amounts.
• Other Information: Indicate additional important information or content mentioned in the OTC monograph.

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This is the stage where we verify if the product maintains stability and efficacy in the production environment.

Process Validation

Verifies if the API components (Active Pharmaceutical Ingredient) in the product are produced as intended. (API assay Test / Long Term ST/CT)

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In this stage, various tests related to product efficacy and stability will be conducted. The SPF and expiration date will be determined through these tests.

FDA SPF Value Testing

In addition to standard safety tests required for cosmetics or OTC products, sunscreens will be tested to determine SPF Value, which can begin once final approval is given for the product sample.

Method VALIDATION

To conduct Actives Testing, you must work with an accredited lab to ensure that there is a proven method for detecting an active ingredient and its concentration. This process is known as Method Validation, and it usually takes about 4-8 weeks to complete.

PET (Preservative Efficacy Test)

PET is a laboratory test used to assess the effectiveness of preservatives in cosmetic and personal care products in preventing microbial contamination per USP guidelines.

Accelerated ST/CT

6 months of completed accelerated study = 2 years of expiration dateerated.

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The OTC production process consists of the following stages:

Formulation and Container Development -> Pre-Production Testing -> Production Preparation -> Production Execution -> Post-Production Testing -> Shipping.

Step 01: Formulation and Container Development

This stage involves developing the formulation and container. Based on development inquiries, formulation samples are created, and specifications for the formulation and container are finalized.

Step 02: Pre-Production Testing

Various tests related to the product's efficacy and stability are conducted. This includes confirming SPF (Sun Protection Factor), expiration date (EXP), and more.

Step 03: Production Preparation

This stage involves preparing raw materials and other necessary components for production. The production quantity needs to be confirmed as the process is based on the required quantity.

Step 04: Production Execution

Actual manufacturing is carried out according to the production plan. The production period may vary depending on the quantity, and batch testing and quality inspections are conducted.

Step 05: Post-Production Testing

This stage verifies that the product maintains stability and efficacy in the production environment.

Step 06: Shipping

After production and testing are completed, the product is shipped to the designated location. The transportation period may vary depending on the destination and shipping conditions.

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Development costs vary depending on the type of product and the testing requirements.

Please leave an inquiry, and a CTKCLIP expert will provide you with the necessary information.

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At CTKCLIP, we specialize in developing OTC products classified in the U.S. as sunscreens, acne treatments, and skin protectants.

If you wish to develop other types of OTC products, please select 'Other' in the inquiry section and specify the product you want to develop. We will review your request and get back to you

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Over-the-Counter (OTC) medications are those that can be bought without a prescription in the United States. Common examples include sunscreens, acne treatments, and skin protectants. These products are easily accessible to consumers, offering a convenient way to manage everyday health and skincare concerns without needing a doctor's prescription.

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For International delivery, we only accept US dolloars as payment currency. The actual amount of payment may differ from the price indicated in your Sample Bag depending on the USD exchange rate of your bank.

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Please send us the bench color samples. We can check with our lab to see if the bench color can be formulated.

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Clean beauty remains as one of the biggest macro trends in the market. With the all-time high demand for Clean Beauty, consumers are demanding more transparency, education, and improved navigation in the complex beauty landscape. CTK Clean complies with the Clean standards of general-purpose distribution channels to make your development easier and your consumers happier (ex : Sephora Clean).

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OTC stands for over the counter, general pharmaceuticals that you can purchase without doctor's prescription. In the USA, SPF products, acnes products and etc are considered as OTC products.

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Once your inquiry is assigned to our sales member, PIC will contact you and guide you to the next process. CTK supports full-service so you don't have to worry about supplying other parts.

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PCR stands for post consumer recycled, package produced with recycled plastic. If you need more information, please send us an inquiry through CLIP.

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Yes, we produce OTC products in Korea. If you need to produce it in USA, we can transfer the formula to our US factory for the final production (details will be communicated during the project development).

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No. However, there can be a cancellation charge if the project is canceled in the middle.

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It is possible. There will be 5% handling charge for the package.

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Yes, it is possible. Please send us an inquiry through CLIP with your request. PIC will contact you for a benchmark sample and we can develop it from there.

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It is possible, but please be sure to finish the compatibility test with the package you are tyring to use. Also, please check if the filling machine is compatible with the formula. We recommend you use CTK's full-service as we have formula and package experts who can guide you through each process.

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It depends on the products. Please send us an inquiry through CLIP.

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We can only provide with our default color during the inquiry stage. 

Once the project officially starts, we can support you with different colors based on your bench color samples.

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Our default samples are normally white or transparent. However, once you have been assigned to our sales manager, you can consult with them for a different colored sample.

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Please send us the inquries through CLIP. We will guide you with the deco area for each package.

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Based on the B2B service, the company shall provide the customized sample at the service level under the condition that the prescribed shipping cost and packing cost are borne by the member, which is incurred when providing the sample requested for the purpose of product development.

For the above reasons, exchanges, returns, and refunds are not possible.

But If you receive damaged products, please contact us with a photo within 7 days of receiving the product.

We will follow up as soon as possible.

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Cancellation is only possible within the ""Cancellation Until "" indicated in the status of [Track Sample].

After the deadline, the [Cancel Payment] button disappears then cancellation is not possible.

If you would like to cancel, please clik [Cancel Payment] button ( [My clips] > [Track Sample] )

Refund will be made through the same payment method.

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Timeframe for fulfilling sample orders is as follows: 

Sample Preparation: could take up to 2 weeks (depending on availability) 

Delivery: 3~8 days (depending on region)

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Please click the products you want > click [REQUEST SAMPLE] >Add to [CART] > Fill out Address > Proceed to Pay. 

Confirmation email will be sent usually within a few minutes of successful payment. 

You may check the status of the sample by visiting [TRACK ORDER].

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After all the development and the tests are finished, procurement will be started upon PO. Normally, it takes about 3 months for the first production. In case of the re-orders, lead time can be shortened through further discussion.

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We are committed to providing a timely response to your inquiries through CLIP. Our goal is to get back to you within 48 hours of receiving your inquiry.

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It depends on your launching location, but normally it takes about 3 to 6 months at the minimum.