Active Ingredient
Miconazole Nitrate 2%
Radthary Groin Antifungal Cream
FDA Label NDC 87786-062
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Radthary Groin Antifungal Cream (NDC 87786-062). 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 jock itch (tinea cruris), and ringworm (tinea corporis)
·relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort associated with jock itch
Warnings
For external use only.
Do Not Use
·on children under 2 years of age unless directed by a doctor
·on nails or scalp
·avoid contact with the eyes
When Using
When using this product avoid contact with the eyes
Stop Use
·irritation occurs or gets worse
·there is no improvement within 2 weeks (for jock itch) or 4 weeks (for athlete’s foot or ringworm)
Ask Doctor
·irritation occurs or gets worse
·there is no improvement within 2 weeks (for jock itch) or 4 weeks (for athlete’s foot or ringworm)
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
·cleanse the affected area with mild soap and water, pat dry
·dispense 2 pumps of cream onto clean fingers
·apply a thin layer over the affected area twice daily, morning and night, or as directed by a doctor
·for jock itch, use daily for 2 weeks
·wear loose-fitting, well-ventilated clothing and change underwear daily
·for first-time users, do a small patch test before full
Other Information
·store at 59°F to 86°F (15°C to 30°C)
Inactive Ingredients
Water, Allantoin, Beeswax, Cedarwood Oil,Cottonseed Oil, Jojoba Oil, Lavender Oil,Magnesium Oxide, MCT Oil, Silver Stearate, Zinc Oxide.
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