Product Choices: Rebranding, Timing, and Starting from Scratch
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A typical range of products in a dermatologist s own line includes basic cleansers; bleaching agents; shampoos; AHAs; sunscreens; topical antioxidants such as green tea, grape seed extract, and stable vitamin C; growth factors; retinols; and even new AHA and sunscreen formulations that incorporate antioxidants and liposomal delivery systems Companies that provide such OTC and private-label products cite ease of manufacture, high patient and physician satisfaction, and stability of products Stable, efficacious skin care products are not easy to formulate, however The easiest, lowest-risk approach to starting one s own line is to work with one of the smaller companies that already carries the type of product(s) of interest and requires low minimums in the initial order volume If this rebranding is successful, new products can be easily added to the line At that point, the physician might want to branch out with a unique formula or two From conception of the plan to release of a new line of products, developing a new cosmetics or cosmeceutical line can take anywhere from 6 months to a year If a practitioner is able to quickly identify a company to work with and that company already provides the desired products for rebranding, the business could take off in a few months If a practitioner hopes to peddle a unique formula, there are additional associated financial and time costs Developmental laboratory fees can range from $15,000 to $50,000 per product (Simple formulations produced at smaller laboratories more likely incur research and development charges of $1000 to $5000) In addition, the FDA requires a 90-day stability assessment for an established product that is to be tweaked with the addition of a new ingredient or two according to a physician s specifications If a physician
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COSMETIC DERMATOLOGY: PRINCIPLES AND PRACTICE
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TABLE 27-1 Product Label Quote Rangea POLYLAMINATE 5000 LABELS 1-Color 2-Color 3-Color 4-Color $0143 ea $0152 ea $0162 ea $0183 ea 10,000 LABELS $0106 ea $0111 ea $0116 ea $0122 ea PAPER W/COATING 5000 LABELS $0075 ea $0085 ea $0094 ea $0173 ea 10,000 LABELS $0058 ea $0064 ea $0069 ea $0113 ea
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a This is a representative quote range for an 8-oz body lotion label, listed by label material and number of colors used Note: The larger the volume, the less signi cant the additional charge for added colors Polylaminate labels are generally 35% to 40% more expensive than paper labels
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decides to change the packaging on an established product, retesting is required The same is true if anything is changed in the formulation (eg, adding or removing a fragrance or an antioxidant) It is recommended that more than one variation of the formulation be submitted simultaneously in case one separates It is best to order packaging at least 2 months into the stability-testing process Although a product may be perfectly stable, some types of packaging might not be ideally suited to it Experienced formulators should know which resins have the best track records in terms of maintaining stability when exposed to certain elements or compounds (eg, light exposure causes decomposition of antioxidant products) It takes 2 to 4 months for packaging to arrive, and typically another 3 weeks or more for inclusion in the manufacturing schedule (once all components, including packaging, have arrived at the manufacturer s plant) Formulating new products from scratch, rather than relabeling, is an easier enterprise if the product is a nondrug, which contains no active ingredient as defined by the FDA Examples include antioxidant products, cleansers, shampoos, and AHAs Stability does not have to be established in these cases Some companies will still perform such testing, though, as they prefer to manufacture under pharmaceutical guidelines As stated previously, prescription or OTC drugs (defined as containing an active ingredient and listed on the back label) must undergo stability testing Examples of these products include sunscreens, prescription and OTC acne products, and antifungals
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