Otc - Active Ingredient
Active Ingredient
Undecylenic Acid 25.0%.
Purpose Antifungal
Toenail Fungus Treatment Gel
FDA Label NDC 85595-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Fengda Technology Co., Ltd. for the product Toenail Fungus Treatment (NDC 85595-002). 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, otc - keep out of reach of children, warnings, inactive ingredient, indications & usage, dosage & administration, 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
Peeling Fungal Nail
Promotes HealthyNail Growth
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away
Warnings
Warnings
For external use only doctor
Do not use On children under 2 years of age unless directed by a
rinse thoroughly with water
When using this product-Avoid contact with eyes If contact occurs,
improve within 4 weeks
Stop use and ask a doctor if*Irritation occurs Condition does not
Inactive Ingredient
Solution No.1 : ACHYRANTHES BIDENTATA WHOLE,DIPSACUS ASPERROOT, NEPETA CATARIA WHOLE, SAPOSHNIKOVIA DIVARICATA ROOT,ELEUTHEROCOCCUS SENTICOSUS ROOT OIL, BRUCEA JAVANICA
WHOLE, LYCIUM CHINENSE WHOLE.
Solution No.2: RHEUM PALMATUM WHOLE, LINDERA AGGREGATAROOT, SALVIA MILTIORRHIZA WHOLE, MELIA AZEDARACH WHOLE,
CYPERUS ROTUNDUS WHOLE, DOLOMIAEA SOULIEI ROOT.
Indications & Usage
First, use Solution No.1 to remove the fungal nail. After the fungalnail falls off, use Solution No.2 to promote the regeneration ofhealthy nails.Please refer to the detailed usage steps in the instruction manualbefore use.
Dosage & Administration
First, use Solution No.1 to remove the fungal nail. After the fungalnail falls off, use Solution No.2 to promote the regeneration ofhealthy nails.Please refer to the detailed usage steps in the instruction manualbefore use.
Uses
* Please review the disclaimer below.
