Active Ingredient
Miconazole Nitrate 2%
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Charmpoo Antifungal Body Cream (NDC 87786-042). 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, 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.
Miconazole Nitrate 2%
Antifungal
■ Treats most athlete's foot, jock itch, and ringworm
■ Relieves itching, scaling, cracking, burning, redness, irritation, and discomfort
·For external use only.
■ On children under 2 years of age unless directed by a doctor
■ Avoid contact with the eyes
■ Irritation occurs
■ There is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch
■ Irritation occurs
■ There is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch
If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.
■ Wash the affected area and dry thoroughly
■ Apply a thin layer of the product over the affected area twice daily, morning and night, or as directed by a doctor
■ Supervise children in the use of this product
■ 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
■ For athlete's foot and ringworm, use daily for 4 weeks
■ For jock itch, use daily for 2 weeks
■ If the condition persists longer, consult a doctor
■ This product is not effective on the scalp or nails
Purified Water, Petrolatum, Light Liquid Paraffin, Glycerin, Stearic Acid, Triethanolamine, Aloe Barbadensis Leaf Juice, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Stemona Sessilifolia Root Extract, Dictamnus Dasycarpus Root Bark Extract, Euphorbia Extract, Borneol, Menthol, Tocopherol.
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