Otc - Active Ingredient
Active ingredientPurposeUndecylenic acid 25%Antifungal
Ivera Antifungal Pen Liquid
FDA Label NDC 87365-006
8 label sections · Submitted to the FDA by Jiangxi He-oumei Health Industry Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi He-oumei Health Industry Co., Ltd. for the product Ivera Antifungal Pen (NDC 87365-006). 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, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Treats most athlete's foot (tinea pedis)
Treats most ringworm (tinea corporis)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.
Warnings
Warnings
For external use only.
Indications & Usage
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation occurs, if there is no improvement within 4 weeks, or if the condition worsens.
Dosage & Administration
Clean and dry the affected area. Apply a thin layer to the affected area by using the brush tip twice daily (morning and night) or as directed by a doctor.
Inactive Ingredient
Inactive ingredients
Ethanol, Propylene Glycol, Salicylic Acid, Disodium EDTA, Purified Water, Glycerin, Polysorbate 80, Phenoxyethanol, Caprylyl Glycol
Package Label.Principal Display Panel
Package (44033aabe27034c01952c0ae18815f6b)
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