Otc - Active Ingredient
Undecylenic Acid 25%
Cysndra Fungal Nail Revitalizer Liquid
FDA Label NDC 87681-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Xinhongda Trading Service Co., Ltd. for the product Cysndra Fungal Nail Revitalizer (NDC 87681-012). 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
Antifungal
Indications & Usage
USE: For superficial skin fungalinfections, skin candidiasis,onychomycosis.
Warnings
·For external use only.
· Contraindicated for children,pregnant and lactating women.
· Prohibited for those who are allergic to this product. Allergic persons should be cautious.
· Prohibit the use ofthisproduct when the properties of the product have changed.
Otc - Do Not Use
Do not use if there is any burning sensation, redness or swelling at the site of application.
Otc - When Using
When Using this product,
avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop Using and ask a doctor if
irritation or redness develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of Children.
In case of accidental ingestion, get medical help or contact a poison control center immediately.
Dosage & Administration
For external use only. Use the brush to apply a layer of liquid directly to the affected nail(s),2-3 times daily for 2-4 weeks.
Inactive Ingredient
ALCOHOL
WATER
UREA
PROPYLENE GLYCOL
SALICYLIC ACID
MENTHOL
HYDROXYPROPYLCELLULOSE
ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
DISODIUM EDTA
GLYCOLIC ACID
Package Label.Principal Display Panel
Label1 (Label1)
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