FDA.reportPublic FDA data

RoyceDerm Anti fungal RELIEF cream

Manufacturer
RoyceDerm LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:17

Label at a glance#

ProductRoyceDerm Anti fungal RELIEF cream
Active ingredientARTEMISIA AFRA TOP, SALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Artemisia extract 3%

Salicylic acid 2%

OTC - PURPOSE SECTION

Anti-fungal

DOSAGE & ADMINISTRATION SECTION

Relieves and helps prevent recurrence of fungal infections:itching, flaking, scaling, redness,and irritation.

INACTIVE INGREDIENT SECTION

Water, Borneol, Sophora Flavescens Root, Cnidium Monnieri Fruit, Kochia Scoparia Pollen, Dictamnus Dasycarpus Root, Smilax Glabra Whole.

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - ASK DOCTOR SECTION

if you are allergic to ingredients in this product.

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.

OTC - STOP USE SECTION

condition worsens or does not improve after regular use as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swalloWed,get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

  • Apply a small amount to the problem areas with circular motions for 3 minutes till the skin absorbs the cream.
  • Apply it 2-3 times a day for the best result.
  • Continue to use for 3-5 days after symptoms resolve to prevent a recurrence
  • Do not use it on pregnant women & children under 12 years of age unless directed by a doctor.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860009297067GTIN-13: 0860009297067
EAN-13: 0860009297067
GTIN-12: 860009297067
UPC-A: 860009297067
GTIN storage (14 digits): 00860009297067		package.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-013-01RoyceDerm Anti fungal RELIEF cream100 g in 1 CARTONCREAM1001

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-01385424-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BASSIA SCOPARIA POLLEN07A108ZKW5IACT
DICTAMNUS DASYCARPUS ROOT6153LEN214IACT
SMILAX GLABRA WHOLEH51N91QNEBIACT
ARTEMISIA AFRA TOPFCU6WET6AAACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
CNIDIUM MONNIERI FRUITV1IA3S3CUSIACT
WATER059QF0KO0RIACT
BORNEOLM89NIB437XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoyceDerm Anti fungal RELIEF creamSALICYLIC ACID 2%RoyceDerm LLC47ec6277-e40f-af82-e063-6294a90ac8c12026-01-08WarningsExact identifier
ndc (package): 85424-013-01
ndc (product): 85424-013
ndc11 (package): 85424001301
spl id: 47ec6277-e410-af82-e063-6294a90ac8c1
spl set id: 47ec6277-e40f-af82-e063-6294a90ac8c1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.