Otc - Active Ingredient
Tolnaftate
Flawless Nails
FDA Label NDC 76348-990
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Flawless Nails (NDC 76348-990). 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 - questions, statement of identity, recent major changes, other safety information, inactive ingredient, otc - purpose, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Questions
MyFlawlessNails LLC
Fairfield, CT 06824
www.MyFlawlessNails.com
Statement Of Identity
FLAWLESS NAILS
Nail Fungus Eliminator
Medical Strength
Clinically Proven
15ML (O.5FL.OZ)
Recent Major Changes
No major changes in Directions. We forgot to save the section and had to retype it.
Only changes made in Dosage were the removal of bullets and unapproved punctuation.
Other Safety Information
Other information: Store at 68° - 77°
Inactive Ingredient
Inactive Ingredients
C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonium Zeylanicum (Cinnamon Bark) Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove Bud) Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil,
Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromaticum (Clove Bud) Oil, Thymol, Tocopherol Acetate, Trimethyl-Adipic Acid Copolymer.
Otc - Purpose
Antifungal
Indications & Usage
Uses
- proven clinically to cure most:
- athlete's foot (tinea pedis)
- ringworm (tinea corporis)
- Effectively soothes and relieves:
- itching
- burning
- cracking
- helps prevent most athlete's foot from coming back with daily use
Warnings
Warnings
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 the eyes
Stop use and ask a doctor if
- there is no improvement within 4 weeks
Keep out of reach of children.
Get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
Otc - When Using
When using this product, avoid contact with the eyes
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions
clean the affected area and dry thoroughly
apply a thin layer over the affected area twice daily
supervise children in the use of this product
for athletes foot pay special attention to the spaces between toes
use daily for 4 weeks
Package Label.Principal Display Panel
FLAWLESS NAILS LABEL AND FLAWLESS NAILS BOX
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