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Meet EarthMed: OTC Products, Manufacturing, and Product Development

Sep 21
3 min read

EarthMed is an FDA-registered drug manufacturing establishment based in Columbia, South Carolina. We manufacture finished over-the-counter products, develop new formulations, and support businesses through wholesale, white label, private label, and pharmaceutical consulting services.


Although our current consumer product line primarily features OTC topicals, EarthMed is not limited to topical manufacturing. As our company grows, we are developing additional product categories and dosage forms to serve consumers, retailers, and businesses seeking an experienced manufacturing partner.


More Than a Topical Product Brand


EarthMed’s current finished-product portfolio includes medicated balms, lotions, creams, and other topical formats. These products are formulated around recognized OTC active ingredients such as menthol, allantoin, and salicylic acid.


Our product-development capabilities extend beyond topicals. EarthMed is working toward an expanded portfolio that may include chewables, ingestible products, and other formats based on the product’s intended use, ingredients, regulatory category, manufacturing requirements, and market.


This broader direction allows EarthMed to support several types of customers:


  • Consumers seeking finished EarthMed products

  • Retailers adding OTC products to their inventory

  • Businesses interested in established formulations

  • Brands developing customized products

  • Companies seeking regulatory or manufacturing support


Meet EarthMed: OTC Products, Manufacturing, and Product Development
Meet EarthMed: OTC Products, Manufacturing, and Product Development

Formulation Begins With the Product’s Purpose


Product development involves more than combining popular ingredients. Before a formula is finalized, the manufacturer must understand what the product is intended to do and how it will be marketed.


Important considerations may include:


  • Intended use and product classification

  • Active and inactive ingredients

  • Ingredient concentrations

  • Dosage form and method of application

  • Flavor, texture, scent, or appearance

  • Packaging compatibility

  • Testing requirements

  • Labeling and marketing claims

  • Storage conditions and proposed shelf life


For an OTC drug, claims must be connected to the recognized active ingredient and appropriate regulatory pathway.


EarthMed at a Glance: OTC Products, Manufacturing and Quality, Product Development, and Business Services
EarthMed at a Glance: OTC Products, Manufacturing and Quality, Product Development, and Business Services

Manufacturing Supported by Documented Controls


Consistent manufacturing depends on structured systems that guide how materials are received, products are made, activities are documented, and finished batches are reviewed.


EarthMed’s operations are supported by controls that may include:


  • Written standard operating procedures

  • Raw-material and packaging controls

  • Approved master manufacturing records

  • Batch production records

  • Equipment cleaning and maintenance procedures

  • In-process checks

  • Product-specific testing

  • Quality-unit review

  • Finished-product release procedures

  • Complaint handling and traceability


These activities work together as part of the overall manufacturing and quality system.


Transparency Through Product Information


Customers and business partners should be able to identify what they are purchasing and locate relevant product information.


EarthMed provides access to available Certificates of Analysis by product and batch number through our Lab Results page. A COA summarizes the tests performed on an identified sample or production batch.


Product labels also provide essential information. OTC products include a Drug Facts panel identifying the active ingredient, purpose, uses, warnings, directions, and other required information. Consumers should always follow the labeled directions and warnings for the specific product they are using.


Supporting Retailers and Emerging Brands


EarthMed offers several ways for businesses to work with our company.


Wholesale


Wholesale partners purchase finished, EarthMed-branded products for resale. This is the most direct option for retailers seeking established products with existing EarthMed packaging and labeling.


White Label


White label services use an established formulation packaged under the customer’s own brand. Because the finished product is sold under another company’s label, separate labeling, listing, and regulatory responsibilities may apply. EarthMed’s NDCs and OTC claims do not automatically transfer to another company’s branded product.


Private Label and Custom Development


Private label projects are built around the customer’s proposed product, ingredients, format, packaging, and market. Development may involve formulation work, prototypes, ingredient sourcing, packaging evaluation, label preparation, and laboratory testing.


Pharmaceutical Consulting


EarthMed also provides consulting support related to drug-establishment registration, drug listing, NDC-related processes, labeling, quality systems, and OTC manufacturing pathways.


Businesses can compare these options on the EarthMed Services page.


Building EarthMed’s Future


EarthMed began with a strong foundation in OTC topical manufacturing. Our next stage is broader: expanding our finished-product portfolio, developing additional dosage forms, supporting retail growth, and helping other businesses move from product concept to commercial manufacturing.


As we grow, our focus remains on documented processes, responsible claims, appropriate testing, transparent communication, and continued improvement.


Consumers can explore current EarthMed products, while retailers and brands can contact our team to discuss wholesale access, product development, manufacturing, or regulatory consulting.


This article is provided for general educational purposes and is not intended as legal, medical, or regulatory advice.


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