Fungicure Night Cream

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:26:18

Label at a glance#

ProductFungicure Night Cream
Active ingredientCLOTRIMAZOLE
Label structure13 sections

Indications and uses

For the cure of most athlete's foot (tinea pedis) For relief og: itching scaling cracking burning redness soreness irritation discomforts which may accompany this condition.

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of FUNGICURE Night Cream over the affected area twice daily (morning and night), or as directed by a doctor. For athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor. For athlete's foot: Pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Sup...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For the cure of most

  • athlete's foot (tinea pedis)

For relief og:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomforts which may accompany this condition.

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

on children under 2 years of age.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of FUNGICURE Night Cream over the affected area twice daily (morning and night), or as directed by a doctor.
  • For athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
  • For athlete's foot: Pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Supervise children in the use of this product.
  • This product is not effective on scalp or nails.

Other information

OTHER SAFETY INFORMATION

  • Fungicure Night Cream may be applied to exposed nail-beds, to cuticles, around nail edges and under nail tips.
  • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use Fungicure Night Cream until satisfactory results are obtained.
  • This product is not intended to, nor will it, penetrate hard nail surfaces.
  • Keep container tightly closed when not in use.
  • Store away from excessive heat and cold.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, cetyl alcohol, citric acid, dimethicone, disodium EDTA, D-panthenol, glycerin, glyceryl stearate, green tea extract, isopropyl myristate, licorice (glycyrrhiza glabra) root extract, petrolatum, phenoxyethanol, polysorbate 80, purified water, shea butter, sodium citrate, stearyl alcohol, tea tree (melaleuca alternifolia) oil, tocopheryl acetate, urea, willow (salix alba) bark extract, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

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-130072959010812GTIN-13: 0072959010812
EAN-13: 0072959010812
GTIN-12: 072959010812
UPC-A: 072959010812
GTIN storage (14 digits): 00072959010812
Fungicure Night Cream Carton181-0RF 1124 ART v1.0.jpg
QR code linkQR Codetinyurl.com/mswwxuu6Fungicure Night Cream Carton181-0RF 1124 ART v1.0.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
52389-681-02Fungicure Night Cream1 in 1 CARTONCREAM11
52389-681-02Fungicure Night Cream48.2 g in 1 TUBECREAM48.21

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-68152389-681-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
Fungicure Night CreamCLOTRIMAZOLEKobayashi Healthcare International, Inc.43029403-2afd-cfa1-e063-6394a90a99a32025-12-04WarningsExact identifier
ndc (package): 52389-681-02
ndc (product): 52389-681
ndc11 (package): 52389068102
spl id: 43029403-2afe-cfa1-e063-6394a90a99a3
spl set id: 43029403-2afd-cfa1-e063-6394a90a99a3

Reported adverse events (FAERS/openFDA)#

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