Claravie - Gentell LLC

Manufacturer
Gentell LLC
Effective date
2026-09-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-11 03:02:17

Label at a glance#

ProductClaravie
Active ingredientMICONAZOLE NITRATE
Label structure15 sections

Indications and uses

For the effective treatment of: Athlete's foot Jock itch Ringworm Relieves itching, scaling, cracking, and discomfort associated with these conditions.

Dosage and administration

Cleanse 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 and ringworm use daily for 4 weeks; for jock itch use daily for 2 weeks. Pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least on...

Storage and handling

Store between 59°F-86°F (15°C-30°C)

Label contents#

Full prescribing information#

DESCRIPTION SECTION


Powered by nature, perfected by science, the ClaraVie™ skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the effective treatment of:
  • Athlete's foot
  • Jock itch
  • Ringworm
  • Relieves itching, scaling, cracking, and discomfort associated with these conditions.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

On children under 2 years of age unless directed by doctor.

DOSAGE & ADMINISTRATION SECTION

For athlete's foot and ringworm use daily for 4 weeks; for jock itch use daily for 2 weeks.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop use and consult 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).

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • Cleanse 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 and ringworm use daily for 4 weeks; for jock itch use daily for 2 weeks.
  • Pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • This product is not effective on the scalp or nails.

Other Information

STORAGE AND HANDLING SECTION

  • Store between 59°F-86°F (15°C-30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Colloidal Anhydrous Silica
  • Corn Starch

Antifungal Powder

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Miconazole Nitrate 2%

Antifungal PowderAntifungal Powder

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-31661554-316-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
ndc (package): 61554-316-11
ndc (product): 61554-316
ndc11 (package): 61554031611
spl id: 5afdc429-cb45-703c-e063-6294a90a971a
spl set id: 5afdc429-cb44-703c-e063-6294a90a971a

Reported adverse events (FAERS/openFDA)#

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