Categories >> OTC


The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

Stating “Repair Cream”.. may imply that the product will affect the structure or function of the body. Therefore, using those statements will turn the product(s) into an unapproved new drug. It is a prohibited act to market unapproved new drugs in the USA.

Please reference the link below as part of the labeling guidance we refer to:


For more information regarding formulating an OTC product, please contact your Sarati Sales representative.