Active Ingredient
Clotrimazole 1%
Fungicure Night Cream
FDA Label NDC 52389-681
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kobayashi Healthcare International, Inc. for the product Fungicure Night Cream (NDC 52389-681). 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 ingredient, purpose, uses, warnings, ask a doctor before use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
For the cure of most
- athlete's foot (tinea pedis)
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomforts which may accompany this condition.
For relief og:
Warnings
For external use only.
Ask A Doctor Before Use
on children under 2 years of age.
When Using This Product
avoid contact with the eyes.
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 4 weeks.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a poison control center right away.
Directions
- 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
- 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
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?
1-800-792-2582
* Please review the disclaimer below.
