Otc - Active Ingredient
ACTIVE INGREDIENTS.
Zinc undercylenate 18%
undecylenic acid 5%
Derman Antifungal
FDA Label NDC 69772-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Teresa Cecena Dba Genesis for the product Derman Antifungal (NDC 69772-125). 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 otc - active ingredient, otc - purpose, user safety warnings, warnings, otc - do not use, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE
Antifungal
User Safety Warnings
USES
For the treatment of athlete's foot. Relieves itching-scaling-cracking-buring.
Warnings
AVOID CONTACT WITH EYES
Keep this and all drugs out od the reach of children. In case of accidental ingestion. seel professional assistance or contact a poison control center immediately.
Otc - Do Not Use
Do not use in pregnancy and children under 2 years of age unless directed by a physician.
For external use only
In case of accidental ingestion seek professional assistance or contac a poison control center immediately.
Dosage & Administration
Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.
This product is not effective on the scalp or nails.
Inactive Ingredient
Polyethylene Glyctol 500, polythylene glycol 4000, water, glycerin, cetyl alcohol, propylene, gycol, zinc stearate, nonyl phenol sulfate, sodium bisulfite.
Package Label.Principal Display Panel
Otc - Keep Out Of Reach Of Children
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN
Indications & Usage
Wash the affected area and dry throughly. Appy a thin layer of the product over the affected area ttwice daily ( morning and night) or as directed by a physician. Supervise children in the use of this product Pay special attention to space between the toes, wear well fitting, ventilated shoes. Change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician.
This product is not effective on the scalp or nails
* Please review the disclaimer below.
