FDA.reportPublic FDA data

RoyceDerm CoolDefense Refreshing Shower Gel

Manufacturer
RoyceDerm LLC
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:03

Label at a glance#

ProductRoyceDerm CoolDefense Refreshing Shower Gel
Active ingredientTOLNAFTATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1.0%

OTC - PURPOSE SECTION

anti-fungal

INDICATIONS & USAGE SECTION

  • Helps relieve and prevent athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • Relieves itching, cracking, scaling, and discomfort caused by these fungal infections.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

on children under 12 years of age.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnancy or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children. In case of accidental ingestion, seek medical advice immediately or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

  • Apply a generous amount to wet skin.
  • Massage gently to create a rich lather.
  • Leave on for 1-2 minutes for maximum benefits.
  • Rinse thoroughly with water.
  • Use daily for best results.
  • For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store in a cool, dry place. Keep away from direct sunlight and heat sources.

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Globulus Leaf Oil, Menthol, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate (Vitamin E), Citric Acid, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin

OTC - QUESTIONS SECTION

Email service@roycederm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

shower gelshower gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2689792tolnaftate 1 % Medicated Liquid SoapPSN1
2689792tolnaftate 10 MG/ML Medicated Liquid SoapSCD1
2689792tolnaftate 1 % Medicated Liquid SoapSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-007-01RoyceDerm CoolDefense Refreshing Shower Gel250 mL in 1 BOTTLE, PUMPLIQUID2501
85424-007-01RoyceDerm CoolDefense Refreshing Shower Gel2 in 1 CARTONLIQUID21

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00785424-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
AQUA059QF0KO0RIACT
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
TOLNAFTATE06KB629TKVACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
SODIUM CHLORIDE451W47IQ8XIACT
MENTHOLL7T10EIP3AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT

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 CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact identifier
ndc (package): 85424-007-01
ndc (product): 85424-007
ndc11 (package): 85424000701
spl id: 3b3216d6-8cc9-ea89-e063-6294a90ab691
spl set id: 3b3216d6-8cc8-ea89-e063-6294a90ab691

Reported adverse events (FAERS/openFDA)#

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