The following Structured Product Label (SPL) was submitted to the FDA by Foshan Sugar Max Cosmetics Co.,ltd for the product Shailee Tea Tree Body Wash (NDC 84938-009). 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, direactions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Tea Tree Oil (Melaleuca alternifolia) 6X HPx Antifungal treatment
Thyme Oil (Thymus vulgaris) – 6X HPx Antifungal treatment
Oregano Oil 6X HPx Antifungal treatment
Lavender Oil (Lavandula angustifolia) 4X HPx Antifungal treatment
Undecylenic Acid 10X HPx Antifungal treatment
For the treatment of most
● jock itch (tinea cruris)
● ringworm (tinea corporis)
● athlete's foot (tinea pedis)
● tinea versicolor
For relief of:
● itching
● scaling
● cracking
● burning
● irritation
For external use only
Ask a doctor before useon children under 2 years of age.
When using this product, avoid contact with the eyes. If contact occurs rinse thoroughly with water.
Stop use and ask a doctor if
● irritation occurs
● there is no improvement within 2 weeks (4 weeks for ringworm, athlete's foot, and tinea versicolor).
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Read all package directions and warnings before use.
● Use only as directed.
● Clean the affected area with Anti-Fungal Wash and warm water, rinse and dry
thoroughly.
● For best results, leave on for 1-2 minutes before rinsing and drying.
● Use twice daily (morning and night), or as directed by a doctor.
● This product is not effective on scalp or nails.
● For jock itch, use daily for 2 weeks.
● For ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. If condition
persists longer, consult 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.
● Intended for use by normally healthy adults only.
● Persons under 18 years of age or those with highly sensitive or allergic skin should
use only as directed by a doctor.
● Supervise children in the use of this product.
Water (Aqua), Cocamidopropyl Betaine, Sodium Chloride, Glycerin, Citric Acid, Sodium Benzoate, Potassium Sorbate, Aloe Vera Extract (Aloe
barbadensis), Chamomile Extract (Matricaria chamomilla), Xanthan Gum.
Image Description (Image 009)
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