Active Ingredients
Miconazole Nitrate 2%
Claravie Cream
FDA Label NDC 61554-305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Claravie (NDC 61554-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, other information, inactive ingredients, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
Proven clinically effective in the treatment of most:
Athlete's foot
Jock itch
Rinqworm
Relieves itching, scaling, cracking and discomfort that can accompany these conditions
Warnings
For external use only
Do not use on children under 2 years of age unless directed bv a doctor
When using this product avoid contact with eves
Stop use and ask a doctor if 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
In case of accidental ingestion contact a physician or Poison Control Center right away
Other Information
Store between 59°F-86°F (15°C-30°C)
Inactive Ingredients
Caprylic/Capric Triglyceride, Ceteareth-20, Ceteary Alcohol, Chlorocresol, Dimethicone. Disodium EDTA Glyceryl Stearate, Imidazolídinyl Urea, PEG-100 Stearate PEG-40 Castor Oil, Petrolatum, Propvlene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Xanthan Gum, Water
Indications & Usage
Proven clinically effective in the treatment of most: athlete's foot, jock itch, ringworm, Relieve itching, scaling , crackinh and discomfort that can accompany these conditions
Dosage & Administration
Apply thin layer to affected area twice daily (morning and night) or as directed by a physician
Antifungal Cream
* Please review the disclaimer below.
