OTC Products : Poland

Find the best companies to manufacture your over-the-counter creams and lotions.

When producing a cream or lotion, if you add an active ingredient, or make a drug claim and the intended use is to provide a physiological benefit beyond a purely cosmetic effect, it is considered an OTC (over the counter) product.  Some other types of products are toothpastes to prevent cavities, chap-sticks intended to heal, antiperspirant deodorants, some moisteners, suntan lotions claiming SPF, medicated shampoos and soaps for dry skin, dry scalp or dandruff.  You will need to assure OTC Drug Monograph compliance for more than just your product labeling.   The manufacturer will need to provide testing of the active ingredients, stability data, Good Manufacturing Practice compliance and process validation, as well as FDA facility and product registrations.