FDA Label for Fungal Nail Renewal
View Indications, Usage & Precautions
Fungal Nail Renewal Product Label
The following document was submitted to the FDA by the labeler of this product Shenzhen Xiaomai Manufacturing Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Tolnaftate1%
Undecylenic Acid 25%
Purpose
Fungal nails, Athlete's Foot, Tinea Manuum, Jock ltch, Ringwormcaused by fungus and bacterial infection.For all caused by nail fungus, nail discoloration, nail thickening,nail splitting, nail crumbling.
Use
For nails
Warnings
-For external use only
-Keep away from fire and flame
Do Not Use
This product is not a substitute for medication.
When Using
For external use only, do not ingest.
Avoid eye contact; maintain dry and clean skin.
Exercise caution when using on severely ulcerated skin.
Keep out of reach of children.
Stop Use
Keep Out Of Reach Of Chlidren:if swallowed,get medical help or
contact a Poison Control Center right away."
Ask Doctor
When Pregnant or breast-feeding.
Keep Oot Of Reach Of Children
Keep Oot Of Reach Of Children
Directions
Apply the product twice a day, in the morning and at night.For initial use, soak the affected nail in warm water to soften itGently file the nail to make it thinner and remove dirt, beingcautious not to ham the nail bed. Apply the product after this step.After the first application, repeat every 2-3 days. File the surfaceof the affected nail and continue regular usage.*In case ofingestion, seek medical assistance or contact apoison control center immediately.
Other Information
Please store in a cool, dry place away from direct sunlight.
Inactive Ingredients
Undecylenic Acid, Tolnaftate, Ethyl Lactate, Aqua, Lactic Acid,Resacetophenone,Acetic Acid, Sophora Flavescens Extract,Stellera Chamaejasme Leaf/Stem Extract, Crocus Sativus StyleExtract, Eucalyptol, Aloe Barbadensis Leaf Extract, CarthamusTinctorius (Safflower) Seed Oil, Hydrogenated PolyisobuteneLavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil, PrunusAmygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum(Sesame) Seed Oil,Simmondsia Chinensis (Jojoba) Seed Oil.Tocopheryl Acetate, Olea Europaea (Olive) Fruit Oil.
Package Label.Principal Display Panel
* Please review the disclaimer below.
