Active Ingredients
Salicylic acid…………12%
Drmitsui Foot Antifungal Treatment Spray
FDA Label NDC 87096-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhenping Renren Industry Co., Ltd. for the product Drmitsui Foot Antifungal Treatment (NDC 87096-004). 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, inactive ingredients, directions, dosage & administration, general precautions, warnings, otc - 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
Antifungal
●BAD SMELLS
●CRACKING
●BURNING
●SCALING
●ITCHING
Inactive Ingredients
Water,
Sophora flavescens root bark,
Cudrania tricuspidata root bark,
Cnidium monnieri fruit,
Tea tree oil,
Ethanol.
Directions
Suitable for individuals experiencing suboptimal health conditions such as athlete's foot, foot odour, and excessive foot perspiration.Relieves foot discomfort and promotes foot health.
Dosage & Administration
●Wash the affected area and dry thoroughly.
●Spray an appropriate amount onto feet.Use 2-3 times daily.
●Supervise children in the use of this product.
●Pay special attention to spaces betweenthe toes; wear weil-fitting, ventilated shoesand change she es and socks at least once daily.
●Use daily for 4 weeks; if condition persists longer, ask a doctor.
●To prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor).
●This product is not effective on scalp or nails.
General Precautions
Seal tightly and store in a cool, dry, well-ventilated place.
Warnings
●For external use only. Do not ingest or allow contact with eyes.
●Keep out of reach of children.
●Do not take care of children under 2 years of age unless directed by a doctor.
●This product is a health supplement and does not replace pharmaceuticals or medical devices for treatment.
Otc - Keep Out Of Reach Of Children
●Keep out of reach of children.
Questions
TELEPHONE NUMBER:1076-482-3458
TIME:09:00-18:00
Rems Administrative Information
DISTRIBUTOR
Mitsui Pharmaceutical Co., Ltd.
ADDRESS
10-24 Mega Awaza Building, 3-Chome, Tensilihonmachi, Nishi-Ku, Oban City, Osaka Prefecture.
MANUFACTURED BY
Zhenping Renren Industry Co., Ltd.
ADDRESS
No.10, Xinxing Road, Chanye Jiju District, Zhenping County, Nanyang, Henan, China.
Label
Principal Display Panel (Label)
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