Dermatin Antifungal Cream Content of Label

Manufacturer
Melaleuca, Inc.
Effective date
2011-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:21

Label at a glance#

ProductDermatin Antifungal
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
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 athlete's 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  acrylates/C10-30 alkyl acrylates crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, dimethicone, glyceryl stearate and PEG-100 stearate, propylene glycol, SD alcohol 40B, steareth-2, steareth-21, stearic acid, T36-C5® Melaleuca alternifolia (Tea Tree) leaf oil, triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label
image of label

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
54473-206-012019-11-13C16284748780-197449f38-be7f-f6ea-e053-dbdaa90aa703Dermatin Antifungal Cream Content of Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H651
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H651

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
54473-20654473-206-01

Ingredients#

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

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

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
6354bcb4-fef2-40c1-ac9b-6cda56e038ee5ce14151-31cc-4e3f-ac32-008fe8bc2f3e2011-02-17WarningsExact identifier
spl id: 6354bcb4-fef2-40c1-ac9b-6cda56e038ee
spl set id: 5ce14151-31cc-4e3f-ac32-008fe8bc2f3e

Reported adverse events (FAERS/openFDA)#

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