The following Structured Product Label (SPL) was submitted to the FDA by Yitongbada (shenzhen) International Trade Co., Ltd for the product Fungifree Nail Fungus Treatment (NDC 83364-005). 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 package label.principal display panel, otc - active ingredient, otc - purpose, indications & usage, dosage & administration, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients Purpose
Ketoconazole 1.7%...................................................................................................................Anti-fungal
Tolnaftate 1.0%.........................................................................................................................Anti-fungal
Treatment of fingernail and toenail fungus
Uses
For external use only
Do not use on children under 2 years of age unless directed by a doctor.
When using this product avoid contact with eyes.
Stop and ask a doctor if - irritation occurs - there is no improvement within 6 weeks
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Warnings
Directions
-Soak your nails in warm water for 5 minutes, then dry them.
-Cut and trim affected nails.
-Dip the brush (attached on cap) into the treatment solution.
-Apply the solution over the affected parts, including the root(s) of the nail(s).
-Use 2 times a day, in the morning and before sleep.
Inactive ingredients Aqua, Sorbitol, Ethanol, Propylene Glycol, Salicylic Acid, Deacetylated Chitin, Angelica Dahurica, Lactic Acid, Chlorhexidine Acetate, Laurocapram
Other information store at 10-35°C (50.0-95.0°F)
* Please review the disclaimer below.
