Active Ingredient
Undecylenic Acid 10%...................Antifungal
Diabetic Antifungal
FDA Label NDC 71521-391
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lavior Inc for the product Diabetic Antifungal (NDC 71521-391). 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 ingredient, purpose, uses, warnings, do not use, stop use and consult a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
Cures most
- athlete's foot (tinea pedis)
- jock itch (tinea cruris)
- ringworm (tinea corporis)
Relieves itching, burning, cracking, and scaling.
Warnings
For external use only. Avoid contact with eyes.
Do Not Use
on children under 2 years of age unless directed by a doctor
Stop Use And Consult A Doctor If
irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- read all warnings and directions
- use only as directed
- 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 athletes’ foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.
- this product is not effective on the scalp or nails
- wash hands after each use
Other Information
store at room temperature
Inactive Ingredients
Water/Aqua/Eau, Propanediol, Inula Viscosa Flower/Leaf/Stem Extract, Urea, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Arachidyl Alcohol, Zea Mays (Corn) Starch, Behenyl Alcohol, Dimethicone, Pentaerythrityl Tetraethylhexanoate, Synthetic Beeswax, Glycerin, Phenoxyethanol, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire de Candelilla, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire de Carnauba, Arachidyl Glucoside, Glyceryl Stearate SE, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, ButyrospermumParkii (Shea) Butter, Ethylhexylglycerin, Disodium EDTA, Xanthan Gum, Hydroxypropyl Bispalmitamide MEA, Polyglyceryl-2 Stearate, Glyceryl Stearate, Palmitic Acid, Stearyl Alcohol, Pentylene Glycol, Isomerized Safflower Acid, Caprylyl Glycol
Questions?
Call toll free 1-844-474-2552 or visit www.lavior.com
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