Active Ingredient
Undecylenic Acid 25%
Zynthix Solution
FDA Label NDC 87575-4041
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 Siwei Yijiu Trading Co., Ltd. for the product Zynthix (NDC 87575-4041). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
- For the treatment of most athlete’s foot, jock itch, and ringworm.
- Relieves itching, burning, cracking, and scaling.
Warnings
- For external use only.
- This product is not effective on the scalp.
- Flammable. Keep away from fire or flame.
Do Not Use
- On children under 2 years of age unless directed by a doctor.
- For diaper rash.
When Using This Product
- Avoid contact with eyes.
- May cause mild stinging or burning sensation on broken skin.
Stop Use And Ask A Doctor If
- Irritation occurs or gets worse.
- There is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch).
Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area and dry thoroughly.
- Twist off the cap, rotate the bottom to dispense solution to the brush.
- Apply a thin layer to the affected area twice daily (morning and night) or as directed by a doctor.
- For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- Supervise children in the use of this product.
Other Information
- Store at room temperature 15°-30°C (59°-86°F).
- Protect from excessive heat and direct sunlight.
Inactive Ingredients
Alcohol denat, Borneol, Glycerin, Isopropyl alcohol, Menthol, Water.
Questions?
213-396-1046 / [email protected]
Box Front Panel
ZYNTHIX
ANTIFUNGAL PEN
25% Undecylenic Acid
Maximum Strength
- Helps Treat Fungal Infections
- Relieves Itching & Burning
- Supports Healthy Nails
NET:12ml/0.42fl.oz
(3x4mL)
* Please review the disclaimer below.
