FDA.reportPublic FDA data

Dermatin

Manufacturer
Melaleuca, Inc.
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:58:49

Label at a glance#

ProductDermatin Antifungal
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Clotrimazole 1%

OTC - PURPOSE SECTION

Purpose
Antifungal

INDICATIONS & USAGE SECTION

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • Relieves itching, burning, cracking, scaling, and discomfort accompanying these conditions

WARNINGS SECTION

Warnings
For external use only

  • When using this product avoid contact with the eyes

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
  • children under 12 years of age should be supervised in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes: change shoes and socks at least once daily
  • for athletes foot and ringworm, use daily for 4 weeks: for jock itch, use daily for 2 weeks
  • this product is not effective on scalp or nails

INACTIVE INGREDIENT SECTION

Other ingredients  Water, T36 C5 Melaleuca Oil, Stearic Acid, Cetyl alcohol, SD Alcohol 40B, Glyceryl Stearate and PEG 100 Stearate, Steareth 21, Propylene Glycol, Dimethicone, Acrylates/C10-30 Alkylacrylates Crosspolymer, Triethanolamine, Steareth 2, Benzyl Alcohol, Methylsothiazolinone, BHT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermatinPeelawayDermatinPeelaway

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN7
1112455Dermatin Antifungal 1 % Topical CreamPSN7
1112455clotrimazole 10 MG/ML Topical Cream [Dermatin]SBD7
309367clotrimazole 10 MG/ML Topical CreamSCD7
309367clotrimazole 1 % Topical CreamSY7
1112455Dermatin 10 MG/ML Topical CreamSY7
1112455Dermatin Antifungal 1 % Topical CreamSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-096-012025-04-07C16284748780-19d75b9d1-192c-f424-e053-dadaa90a57ceDermatin Antifungal
54473-096-012025-01-30C16284748780-19d75b9d1-192c-f424-e053-dadaa90a57ceDermatin Antifungal
54473-096-012020-02-04C16284748780-19d75b9d1-192c-f424-e053-dadaa90a57ceDermatin Antifungal
54473-096-012020-01-31C16284748780-19d75b9d1-192c-f424-e053-dadaa90a57ceDermatin Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-096-01DermatinAntifungal14 g in 1 TUBECREAM147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-096DERMATIN ANTIFUNGAL (CLOTRIMAZOLE) CREAM [MELALEUCA, INC.]7Current NDC, Legacy NDC, 1 package rows20250409_e993fa3b-1d85-46b7-bda5-ed875be74c4e.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-09654473-096-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALCOHOL3K9958V90MIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
STEARIC ACID4ELV7Z65APIACT
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
TROLAMINE9O3K93S3TKIACT
BENZYL ALCOHOLLKG8494WBHIACT

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
Dermatin AntifungalCLOTRIMAZOLEMelaleuca, Inc.e993fa3b-1d85-46b7-bda5-ed875be74c4e2025-03-20WarningsExact identifier
ndc (package): 54473-096-01
ndc (product): 54473-096
ndc11 (package): 54473009601
spl id: 30cde80e-e74e-d8f5-e063-6394a90abd48
spl set id: e993fa3b-1d85-46b7-bda5-ed875be74c4e

Reported adverse events (FAERS/openFDA)#

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