Active Ingredient
Miconazole 2%
Roycederm Tinea Treatment Cream
FDA Label NDC 84746-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Yuyaotang Pharmaceutical Co., Ltd for the product Roycederm Tinea Treatment Cream (NDC 84746-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
Help relieve the itching.discoloration, irritation, anddiscomfort with tinea versicolorcorporis, cruris and tinea pedis.
Warnings
for external use only
Do Not Use
Children unde12 years: ask a doctor
When Using
avoidcontact with eyes.If contact occurs, rinse the eyesthoroughly with water.
Stop Use
if condition worsens or does notimprove after reqular use as directed
Ask Doctor
Ask a doctor before use if youare allergic to ingredients in thisproduct
Keep Oot Of Reach Of Children
Keep out of reach of children. lfswallowed, get medical help orcontact a Poison Control Cente(1-800-222-1222)right away.
Directions
Adult and childrenover 12 years or old. Wash handsbefore and after applying thecream. Apply to affected area atthe first sign of blisters, sores, ortingling sensation. Rub in gentlyand thoroughly. Do not use morethan 3 times daily. Children unde12 years: ask a doctor
Other Information
Store atroom temperature and out of directsunlight
Inactive Ingredients
Water,ARTEMISIA EXTRACT IFHFI],SOPHORA FLAVESCENS ROOT. CNIDIUM MONNIERI FRUITKOCHIA SCOPARIA POLLEN
DICTAMNUS DASYCARPUSROOT, SMILAX GLABRA WHOLE
Questions
Visit www.roycederm.com
Principal Display Panel
1 (Label)
* Please review the disclaimer below.
