Active Ingredient
Zinc Undecylenate 10%
Dr. Helexin Antifungal Balm
FDA Label NDC 85587-005
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 Zealous Ecommerce Technology Co., Ltd for the product Dr. Helexin Antifungal Balm (NDC 85587-005). 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
Treats athlete’s foot, Jock itch and worm, Relieves itching, burning, cracking and scaling which accompany these conditions.
Use
Apply a small amount to healthy skin and wait 24 hours to check for irritation
Warnings
Always perform a 24-hour patch test prior to use; discontinue if irritation occurs, avoid application on broken skin or if allergic to nuts, seeds, or essential oils (e.g., almond, tea tree, lavender), and consult a healthcare provider before use during pregnancy, breastfeeding, or for children under 12.
Do Not Use
Avoid application on broken skin or if allergic to nuts, seeds, or essential oils
When Using
Wash the affected area with soap and water, then dry thoroughly.
Stop Use
Discontinue if irritation occurs
Ask Doctor
Consult a healthcare provider before use during pregnancy, breastfeeding, or for children under 12.
Keep Out Of Reach Of Children
Keep Out Of Reach Of Children
Directions
Gently apply a thin layer to the affected area twice daily (morning and night).
Inactive Ingredients
Water，Safflower (Carthamus tinctorius) Seed Oil, Tea Tree (Melaleuca alternifolia) Leaf Oil, Stearic Acid, Cetyl Alcohol, SE - Glyceryl Stearate SE, Tocopheryl Acetate, Glyceryl Stearate, 60 - Polysorbate 60, Glycerin, Urea, Panthenol, Sweet Almond (Prunus dulcis) Oil, Sesame (Sesamum indicum) Seed Oil, Avocado (Persea americana) Oil, Horsetail (Equisetum arvense) Extract, Chamomile (Matricaria chamomilla) Flower Extract, Aloe Barbadensis Leaf Juice, Glyceryl Stearate Citrate, Cetearyl Glucoside, 20 - Polysorbate 20, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Macadamia (Macadamia ternifolia) Seed Oil, Olive (Olea europaea) Fruit Oil, Candelilla (Euphorbia cerifera) Wax, Coconut (Cocos nucifera) Oil, Eucalyptus (Eucalyptus globulus) Leaf Oil, Cetearyl Alcohol*, Geranium (Pelargonium graveolens) Flower Oil, Rice (Oryza sativa) Bran Extract, Sunflower (Helianthus annuus) Extract, Rosemary (Rosmarinus officinalis) Leaf Extract, Tocopherol, Pumpkin (Cucurbita pepo) Seed Oil, Bisabolol, Lavender (Lavandula angustifolia) Flower Oil, Orange (Citrus aurantium dulcis) Peel Oil, Oregano (Origanum vulgare) Leaf Oil, Black Seed (Nigella sativa) Seed Oil, Turmeric (Curcuma longa) Root Extract
Questions
https://drhelexin.com
Email: [email protected]
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