Otc - Active Ingredient
Miconazole Nitrate 2%
Hermon Jock Itch Antifungal Treatment Cream
FDA Label NDC 85398-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Hermon Jock Itch Antifungal Treatment Cream (NDC 85398-032). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - do not use, otc - when using, otc - stop use, 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
Otc - Purpose
Antifungal
Dosage & Administration
- Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
- For effective relief of itching, scaling, cracking, burning, and discomfor
Warnings
For external use only.
Otc - Do Not Use
on children under 2 years of age unless directed by a doctor.
Otc - When Using
avoid contact with eyes.
Otc - Stop Use
- irrition occurs-condition persists
- there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
- clean the affected area and drythoroughly
- apply a thin layer of the productover affected area twice daily(morning and night) or asdirected by a doctor
- supervise children in the use ofthis product
- for athlete's foot, pay specialattention to the spaces betweenthe toes; wear well-fitting,ventilated shoes, and changeshoes & socks at least once daily
- for athlete's foot and ringworm,use daily for 4 weeks
- for jock itch, use daily for 2 weeks
- this product is not effective onthe scalp or nails
Other Safety Information
Do not use if glued carton end flaps are open or if the tube seal is broken
Store at room temperature 59°-86°F (15°-30°C).
Inactive Ingredient
Water, Smilax Glabra Root Extract,Sophora Flavescens Root Extract,Cnidium Monnieri Fruit Extract,Kochia Scoparia Fruit Extract,Pseudolarix Amabilis Bark Extract,Dictamnus Dasycarpus Root BarkExtract, Stemona Tuberosa Root Extract, Mentha Arvensis Leaf Extract, Glycyrrhetinic Acid
Otc - Questions
Tel:573-476-4179
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