Description
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.
Claravie Powder
FDA Label NDC 61554-316
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 61554-316). 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 description, active ingredients, purpose, uses, warnings, do not use, dosage & administration, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Miconazole Nitrate 2% w/w
Purpose
Antifungal
Uses
- For the effective treatment of:
- Athlete's foot
- Jock itch
- Ringworm
- Relieves itching, scaling, cracking, and discomfort associated with these conditions.
Warnings
For external use only.
Do Not Use
On children under 2 years of age unless directed by doctor.
Dosage & Administration
For athlete's foot and ringworm use daily for 4 weeks; for jock itch use daily for 2 weeks.
When Using This Product
Avoid contact with eyes.
Stop Use And Consult A Doctor If
- Irritation occurs.
- 4 weeks (for athlete's foot or ringworm), or
- 2 weeks (for jock itch).
There is no improvement within:
Keep Out Of Reach Of Children
- In case of accidental ingestion contact a physician or Poison Control Center right away.
Directions
- 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
- Store between 59°F-86°F (15°C-30°C)
Inactive Ingredients
- Colloidal Anhydrous Silica
- Corn Starch
Otc - Questions
1-800-840-9041
www.gentell.com
Antifungal Powder
Miconazole Nitrate 2%
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