Package Label.Principal Display Panel
Drug facts
Antifungal Ringworm Cream
FDA Label NDC 85248-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Antifungal Ringworm Cream (NDC 85248-007). 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 package label.principal display panel, otc - active ingredient, otc - purpose, dosage & administration, otc - do not use, otc - when using, otc - ask doctor, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients Purpose
Menthol 8.0%…............................…………………..………………….Anti-Fungal
Miconazole 0.1%…............................…………….……..…………….Anti-Fungal
Otc - Purpose
Uses
Targets Athletes Foot, Psoriasis, Eczema, Ringworm, and Fungal Infections. Relieves itching, irritation, redness, scaling and discomfort.
Dosage & Administration
For external use only
Otc - Do Not Use
Do not use on children under 3 years of age unless directed by a doctor.
Otc - When Using
When using this product avoid contact with eyes.
Otc - Ask Doctor
Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Warnings
Warnings
Indications & Usage
Directions
- Clean and dry the affected area.
- Apply a thin layer of cream 3-4 times daily.
- Use daily for 4 weeks.
- If your condition persists, see a doctor.
- This product is not effective on the scalp or nails. Avoid applying it to the face.
Other Safety Information
Other information
Store away from excess heat and direct sun.
Inactive Ingredient
Inactive ingredients
Chlorhexidine Diacetate, Sophora Angustifolia, Dictamnus Dasycarpus, Kochia Scoparia, Lonicera Japonica, Chrysanthemum Indicum, Phellodendron Amurense, Cnidii Fructus, Petroleum Jelly, Glycerol, Stearic Acid, Cetostearyl Alcohol, Azone, Allantoin, Glycerol Monostearate
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