FDA.reportPublic FDA data

MICOCLEAR

Manufacturer
Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:41

Label at a glance#

ProductMICOCLEAR
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

cures most athlete's foot, jock itch and ringworm relieves itching, burning, cracking, scaling, discomfort and chafing associated with jock itch

Dosage and administration

wash affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock it...

Storage and handling

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. store between 20°-25°C (68°-77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1% (w/w)

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling, discomfort and chafing associated with jock itch

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or 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

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and 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
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other Information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • store between 20°-25°C (68°-77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, cetostearyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, sorbitan monostearate, water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-474-7464

SPL UNCLASSIFIED SECTION

MICOCLEARTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg.Lic.No.: G/25/1362

PRINCIPAL DISPLAY PANEL -45g carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MICOCLEARTM

Clotrimazole Antifungal Cream 1%

Cures most athlete's foot, jock itch and ringworm

Net Wt 1.5 oz (45 g)

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357237350454GTIN-13: 0357237350454
EAN-13: 0357237350454
GTIN-12: 357237350454
UPC-A: 357237350454
GTIN storage (14 digits): 00357237350454		clotrimazole-label-2.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-350-15MICOCLEAR15 g in 1 TUBECREAM151
57237-350-15MICOCLEAR1 in 1 CARTONCREAM11
57237-350-30MICOCLEAR30 g in 1 TUBECREAM301
57237-350-30MICOCLEAR1 in 1 CARTONCREAM11
57237-350-45MICOCLEAR45 g in 1 TUBECREAM451
57237-350-45MICOCLEAR1 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-35057237-350-15, 57237-350-30, 57237-350-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PALMITATE5ZA2S6B08XIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
MICOCLEARCLOTRIMAZOLE ANTIFUNGALRising Pharma Holdings, Inc.d75b7d3c-3f1c-47e1-8122-4645f56a444e2025-11-06WarningsExact identifier
ndc (package): 57237-350-15
ndc (package): 57237-350-45
ndc (package): 57237-350-30
ndc (product): 57237-350
ndc11 (package): 57237035015
ndc11 (package): 57237035030
ndc11 (package): 57237035045
spl id: 3c699592-5b66-406e-ad0e-ed895aab571e
spl set id: d75b7d3c-3f1c-47e1-8122-4645f56a444e

Reported adverse events (FAERS/openFDA)#

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