Active Ingredient
Undecylenic Acid 11%
Gemachlich Zuhause Fungal Nail Revitalizer Liquid
FDA Label NDC 76986-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Gemachlich Zuhause Fungal Nail Revitalizer (NDC 76986-007). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
For Healthier and Stronger Nails.
Use
For superficial skin fungal infections, 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 of this product when the properties of the product have changed.
Do Not Use
Do not use if there is any burning sensation, redness or swelling at the site of application.
When Using
When Using this product, avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
Stop Use
Stop Using and ask a doctor if irritation or redness develops and lasts.
Ask Doctor
In case of accidental ingestion, get medical help or contact a poison control center immediately.
Keep Out Of Reach Of Children
Keep out of reach of Children.
Directions
For external use only. Use the brush to apply a layer ofliquid directly to the affected nail(s),2-3 times dailyfor 2-4 weeks.
Other Information
· If you are using other drugs, please consult your physician or pharmacist before using this product.
· Shielded from light, sealed, stored in a cool place (not more than 20°C).
Inactive Ingredients
Alcohol, Water, Urea, Propylene Glycol, Salicylic Acid, Menthylum, Hydroxypropylcellulose, Zanthoxylum Bungeanum Fruit
Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Glycolic Acid
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