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CTKCLIP, Your trusted partner in OTC manufacturing
Your trusted partner
Adhering to strict regulatory standards and developing innovative formulations.
Understanding the difference between Cosmetics
and OTC products in the U.S. Market.
Why CTKCLIP OTC?
Low quantities, hassle-free – your Fast Track product development with CTKCLIP.
Product Performance on Top
Product Performance on Top
With our extensive experience in global formula development,
we ensure top-performing products for the market.
As for packaging, we recommend solutions that perfectly complement your formula.
Fast Track,
for optimized product
development
Fast Track,
for optimized product
development
With CTKCLIP, you can achieve OTC development 6-10 months faster compared to other companies, enabling a rapid product launch into the market.
Industry average development time: 15 - 24 months
Changes may occur based on formulation, export country, and testing requirements.
Low Order Quantities
Low Order Quantities
CTKCLIP offers flexible OTC production options based on formulation and fill volume, delivering reasonably low quantities of one-third of what other manufacturers require.
Quantities may vary depending on the formula (makeup products: determined by color).
Reliable
Reliable
During FDA audits, which are conducted according to pharmaceutical standards, it's crucial to collaborate with reputable manufacturers registered under Drug Facility Registration, as they can meet rigorous inspection criteria.
Products are produced in certified U.S. facilities with years of OTC manufacturing experience.
Top Priorities are the most important aspects
Top Priorities are the most important aspects
Safety and Effectiveness First By adhering to the OTC monograph, we ensure that our active ingredients are both safe and effective.
Adhering to OTC Labeling Regulations is Crucial
Adhering to OTC Labeling Regulations is Crucial
The criteria for determining whether a product is classified as a cosmetic or an OTC in the U.S. largely depends on the labeling claims.
Therefore, it is crucial to comply with OTC labeling regulations.
CTKCLIP offers expert guidance on labels based on years of experience in OTC development.
Labeling Requirements
Active ingredients, Uses, Warnings, Directions,Inactive ingredients..
What OTC products can be developed?
Below are OTC products that can be developed with CTKCLIP.
Defined as OTC in the United States, these products meet regulatory standards. Select a category and get in touch with us to learn more.
SUNSCREEN SUNSCREEN
In the United States, sunscreens are regulated as drugs, not cosmetics, and are therefore classified as OTC products. If base makeup such as foundation or CC cream contains active sunscreen ingredients, it falls under the category of OTC products.
ACNE TREATMENTS ACNE
When a product contains a certain amount of acne medication active ingredient, it will be classified as an OTC product even if acne is not mentioned in it.
SKIN PROTECTANT SKIN PROTECTANT
A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.
OTC Product Development Process
A streamlined process from development to production.
How To Launch Your OTC Products
Our team of creative engineers includes experts in formulation, planning, and quality, with extensive know-how in supply chain management
STEP 1
Formula & Packaging Development
In this step of formula and packaging development, based on your request, formula samples will be produced and finalized, along with the packaging, considering the specified requirements.
STEP 2 Pre-production Test
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 date.
STEP 3
Production preparation
In this stage, production is handled. This includes sourcing raw materials and preparing subcomponents. Since production progresses based on the quantity to be produced, it is necessary to finalize the production quantity.
STEP 4
Production
Once a plan is made for production and all components and raw materials are cleared, production can be scheduled. Quality control will also perform batch testing and quality checks during and after manufacturing and packaging to verify product consistency and adherence to specifications.
STEP 5
Post-production Test
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
Conducts API content analysis.
Long Term ST/CT
Conducts long-term stability tests.
STEP 6 Ex-factory
Once production and testing are finished, the product will be shipped to the specified destination. The shipping duration may vary depending on the destination and transportation conditions.
FAQ
Uncover answers to the most frequently asked questions in our comprehensive FAQ section.
- What is an OTC Drug Monograph?
-
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.
- What are the OTC labeling regulations?
-
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.
- What is the Post-production Test?
-
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)
- What is the Pre-production Test ?
-
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.
- OTC Production Process
-
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.
- What are the development costs?
-
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.
- Can other products be developed besides sunscreens, acne treatments, and skin protectants?
-
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
- What is OTC?
-
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.
Developing Trustworthy Solutions,
OTC by CTKCLIP
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.
Continuously updated, these regulations ensure that OTC products adhering to the monograph are considered safe and effective in the market.
