Active Ingredients.
Zinc undecylenate 18%
Undecylenic acid 5%
Derman Antifungal Cream
FDA Label NDC 54312-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Compania Internacional De Comercio, S.a.p.i De C.v. for the product Derman Antifungal (NDC 54312-125). 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, do not 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 treatment of athletes foot.
Warnings
For external use only
Do Not Use
on children under 12 years of age unless directed by a doctor.
When Using This Product
avoid contact with the eyes.
Stop Use And Ask A Doctor If
irritation occurs or if 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
- Wash the 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 between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- Use daily for 4 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
Inactive Ingredients
Cetyl alcohol, Glycerin, Polyethylene glycol 500, Polyethylene glycol 4000, Propylene glycol, Sodium bisulfite, Sodium laureth sulfate, Water, Zinc stearate.
Package Labeling:
Label2 (Label2)
* Please review the disclaimer below.
