Active Ingredient
Undecylenic Acid (11%)
Gembooxt Nail Fungus Solution Liquid
FDA Label NDC 76986-016
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 Gembooxt Nail Fungus Solution (NDC 76986-016). 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
Antifungal
Use
• For the relief of itching, burning, and irritation associated with these conditions.
• Helps in the treatment of antifungal infections on skin around nails.
Warnings
• For external use only.
Do Not Use
• Do not use on children under 2 years of age unless directed by a doctor.
When Using
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop Use
• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.
Ask Doctor
• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.
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.
Directions
• Clean and dry affected area.
• Apply a thin layer twice daily (morning and night).
• Continue treatment for at least 4 weeks. For nail fungus, treatment may be required for 8–12 weeks.
Other Information
•Store at 20°-25C(68°-77°F).
•Protect from light.
•Keep container tightly closed.
•See bottom of package for lot number and expiration date.
Inactive Ingredients
Alcohol，Water，Urea，Propylene Glycol，Salicylic Acid，Menthol ，Hydroxypropylcellulose ，Zanthoxylum Bungeanum Fruit Extract，Melaleuca Alternifolia (Tea Tree) Leaf Oil，Disodium EDTA，Glycolic Acid
Questions
Tel.400-055-8876
Manufacturerd: Guangdong Quadrant Ecological Technology Co.,Ltd.
Address: Building B, General Plant, North Shanfen Road, West Songshan Road,Longhu,Shantou,Guangdong,China
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