Package Label.Principal Display Panel
Drug Facts
Fungal Nail Patches
FDA Label NDC 83364-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yitongbada (shenzhen) International Trade Co., Ltd for the product Fungal Nail Patches (NDC 83364-011). 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, dosage & administration, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients Purpose
Tolnaftate 1.0%...........................................................................................................Anti-fungal
Otc - Purpose
Uses
Repairs fungal nail damage and improves nail appearance
Dosage & Administration
For external use only
Otc - Do Not Use
Do not use on children under 3 years of age unless directed by a doctor.
Otc - When Using
When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water
Otc - Stop Use
Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away
Warnings
Warnings
Indications & Usage
Directions
- Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months
Other Safety Information
Other information Store at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun
Inactive Ingredient
Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, Water
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