Active Ingredient
Clotrimazole 1%
Pharmbanner Tea Tree Oil Antifungal Soap. Soap
FDA Label NDC 83818-018
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 Xinxin Yunhai Technology Co., Ltd. for the product Pharmbanner Tea Tree Oil Antifungal Soap. (NDC 83818-018). 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
■ Relieves and helps prevent recurrence of:
- Athlete's foot (tinea pedis)
- Jock itch (tinea cruris)
- Ringworm (tinea corporis)
■ Helps reduce body odor, acne, itching, eczema, and irritated skin caused by fungi.
Warnings
For external use only
Do Not Use
on broken skin or for vaginal yeast infections.
When Using
avoid contact with eyes
Stop Use
if irritation develops or condition worsens
Ask Doctor
if irritation develops or condition worsens
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center.
Directions
■ Use daily in bath or shower.
■ Wet skin and work bar soap into a rich lather.
■ Apply thoroughly to affected areas and surrounding skin.
■ Leave lather on skin for 1-2 minutes before rinsing.
■ Rinse well and dry affected area completely.
■ Use once daily for best results.
■ For athlete's foot: pay special attention to the spaces between toes.
■ Change socks, shoes, and linens daily if possible.
Other Information
■ Store at room temperature, avoid excessive heat and direct sunlight.
■ For best quality, use within 24 months of opening.
Inactive Ingredients
Tea Tree Oil, Eucalyptus Oil, Menthol, Peppermint Oil, Lavender Oil, Clove Oil, Coconut Oil, Palm Oil, Olive Oil, Glycerin, Aqua, Sorbitol, Sodium Hydroxide, Stearic Acid, Propylene Glycol, Tocopherol (Vitamin E), Citric Acid.
Questions
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