Active Ingredient
Terbinafine hydrochloride 1%
Pharmbanner Tinea Versicolor Cream
FDA Label NDC 83818-024
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 Tinea Versicolor Cream (NDC 83818-024). 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
• Cures most athlete’s foot (tinea pedis)
• Cures most jock itch (tinea cruris) and ringworm (tinea corporis)
• Relieves itching, burning, cracking and scaling which accompany these conditions
• Also helps relieve symptoms of tinea versicolor (pityriasis versicolor)
Warnings
For external use only.
Do Not Use
• On nails or scalp
• In or near the mouth or eyes
• For vaginal yeast infections
When Using
• Do not get into eyes. If contact occurs, rinse thoroughly with water.
Stop Use
• Irritation occurs or gets worse
• Symptoms do not improve after 4 weeks
Ask Doctor
• Irritation occurs or gets worse
• Symptoms do not improve after 4 weeks
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• Adults and children 12 years and older:
- Wash the affected area with soap and water and dry completely before applying.
- Apply a thin layer to affected skin once or twice daily as directed.
- For tinea versicolor: apply once daily for 2 weeks.
- Wash hands after each use.
• Children under 12 years: ask a doctor.
Other Information
• Store at controlled room temperature 20°–25 °C (68°–77 °F).
• Do not use if the seal is broken.
Inactive Ingredients
Purified Water (Aqua), Cetyl Alcohol, Stearyl Alcohol, Cetyl Palmitate, Isopropyl Myristate, Polysorbate 60, Sorbitan Monostearate, Benzyl Alcohol, Sodium Hydroxide, Panthenol(1%), Urea(4%), Menthol(0.5%)
Questions
Email: [email protected]
Website: pharmbanners.com
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