Fungicure Anti-Fungal Wash — Kobayashi Healthcare International, Inc. drug label update
Kobayashi Healthcare International, Inc. has updated the drug label for Fungicure Anti-Fungal Wash, specifying its use for treating tinea cruris, tinea corporis, tinea pedis, and tinea versicolor.
This update affects Kobayashi Healthcare International, Inc., as well as regulatory and quality assurance professionals managing over-the-counter (OTC) antifungal product labeling.
The update formalizes the scope of indicated uses and symptomatic relief claims for this OTC antifungal product. While specific changes to the formulation are not detailed in the source, the clear definition of treatable conditions (such as tinea versicolor) and associated symptoms suggests a refined regulatory positioning that may require internal labeling audits for similar products in a firm's portfolio.
Regulatory teams should ensure that all labeled indications for antifungal washes align precisely with approved uses for specific tinea infections. Quality units should verify that current packaging reflects these updated therapeutic claims to maintain compliance with OTC monograph or NDA requirements.
Fungicure Anti-Fungal Wash (Kobayashi Healthcare International, Inc.). Uses For the treatment of most jock itch (tinea cruris) ringworm (tinea corporis) athlete's foot (tinea pedis) tinea versicolor For relief of: itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions.
Open in openFDA / FDA.gov