Active Ingredients
UNDECYLENIC ACID 5%
ZINC UNDECYLENATE 20%
Antifungal Cream
FDA Label NDC 85636-029
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 Earth Surface Trading Co., Ltd. for the product Antifungal Cream (NDC 85636-029). 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 ingredients, purpose, uses, warnings, stop use and ask a doctor if, do not use, when using this product, 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
Purpose
Anti-fungal
Uses
• relieves itching, burning, cracking, and scaling associated with
athlete’s foot, jock itch, and ringworm
• helps relieve symptoms associated with athlete’s foot, jock itch,
and ringworm
Warnings
For external use only
Stop Use And Ask A Doctor If
• irritation occurs
• there is no improvement within 4 weeks (for athlete’s foot &
ringworm) or within 2 weeks (for jock itch)
Do Not Use
• on children under 2 years of age unless directed by a doctor.
When Using This Product
• avoid contact with the eyes
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center
right away at 1-800-222-1222.
Inactive Ingredients
Water,Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Panthenol, Thymus Vulgaris (Thyme)
Flower/Leaf Oil, Centella Asiatica Extract, Menthol, Aloe Vera
Extract, Ceramide NP, Colloidal Oatmeal, Rosemary, Urea, Sodium
Hyaluronate, Cocos Nucifera (Coconut) Oil, Lavandula Angustifolia
(Lavender) Oil, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Geranium
Dosage & Administration
• adults and children 2 years and older: apply a thin layer to the
affected area 2-3 times daily
• children under 2 years: do not use; ask a doctor
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