FDA.reportPublic FDA data

Cura Hongo Lotion (K)

Manufacturer
Pharmadel LLC
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:49:05

Label at a glance#

ProductCura Hongos Antifungal
Active ingredientCLOTRIMAZOLE
Label structure8 sections

Indications and uses

proven clinically effective in the treatment of most: athlete's foot (tinea pedis) jock itch (tinea cruris) ringworm (tinea corporis) for effective relief of: itching scaling cracking burning redness soreness irritation discomfort itching, burning feet itchy, scaly skin between the toes

Dosage and administration

for the treatment of athlete's foot, jock itch, and ringworm: 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 ...

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient Purpose
Clotrimazole 1% w/w............................ Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most:
  • athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)
  • for effective relief of:
  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort
  • itching, burning feet
  • itchy, scaly skin between the toes

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years, unless directed by a doctor.

Stop use and ask a doctor if

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - STOP USE SECTION

consult a doctor before using this product.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for the treatment of athlete's foot, jock itch, and ringworm:
  • 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, consult a doctor 
  • this product is not effective on the scalp or nails

Other information

SPL UNCLASSIFIED SECTION

  • store between 59-85˚F (15-30˚C)
  • do not use if seal over cap is broken, torn, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

polyethylene glycol 400

Distributed by/ Distribuido por:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

Made in India / Hecho en India

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP CuraHongo LiquidPDP CuraHongo Liquid

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-434CURA HONGOS ANTIFUNGAL (CLOTRIMAZOLE) LOTION [PHARMADEL LLC]4Unmatched20241121_1dd8dd6c-23b7-4203-e063-6394a90affb6.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-43455758-434-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT

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
437fc6af-b61d-b18e-e063-6294a90a75b71dd8dd6c-23b7-4203-e063-6394a90affb62025-11-13WarningsExact identifier
spl set id: 1dd8dd6c-23b7-4203-e063-6394a90affb6

Reported adverse events (FAERS/openFDA)#

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