This labelling standard applies to products in cream, ointment, lotion, gel, powder, spray powder, aerosol liquid, solution, foam, or soap form intended to treat jock itch or ringworm. The medicinal ingredients and their concentrations in applicable products are restricted to those specified in this standard. The medicinal ingredients must be identified on product labelling by the names given in this standard. An antifungal agent is a drug which either kills or inhibits the growth and reproduction of fungal cells. A dermatophyte is a fungus that invades and lives upon the skin or in the hair or nails.
Ringworm is a skin infection caused by dermatophytic fungi.
Where no Schedule B monograph exists for the dosage form, specifications should be similar to those of a comparable compendial dosage form. In the absence of a Schedule B standard for any dosage form, testing must be adequate to demonstrate the product's identity, potency, purity and quality. Pharmacopoeial standards for formulated antifungal preparations that are contained in Schedule B publications are shown in Appendix I. Note that this list is intended only as a guide and is not necessarily current or all inclusive. The specifications for all dosage forms should include a description of the dosage form including organoleptic properties as well as physico-chemical testing e.g., pH, specific gravity, viscosity, appropriate to the dosage form. Where antimicrobial preservatives are added, an assay with suitable limits should be included.