Otc - Active Ingredient
Tolnaftate 1%
Undecylenic Acid 25%
Oniadba Nail Fungus Treatment Pen Liquid
FDA Label NDC 85992-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Boyimei Technology Co., Ltd. for the product Oniadba Nail Fungus Treatment Pen (NDC 85992-004). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-fungal
Indications & Usage
Antifungal treatment for fingernails, toenails, and surrounding skin.Effective against fungal nails.athlete's foot, tinea manuum, and ringworm caused by fungi.Addresses nail fungus,discoloration, thickening, splitting, and crumbling
Warnings
Keep away from fire and flames.
Keep out of reach of children.
For external use on nails and the immediately adjacent skin only.
Otc - Do Not Use
Do not use if you experience any signsof sensitivity or irritation.
Otc - When Using
Not for use in the eyes, mouth, or vaginal area
Otc - Stop Use
If the area of application shows increased irritation
If there is no improvement within 8 weeks.
If pregnant or breastfeeding.
Otc - Keep Out Of Reach Of Children
If accidental ingestion occurs, seek medical
assistance or contact a Poison Control
Center immediately.
Dosage & Administration
Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel
Inactive Ingredient
Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel
Package Label.Principal Display Panel
Label4 (Label4)
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