Otc - Active Ingredient
Miconazole Nitrate 2% (Cream)
Clotrimazole 1% (Soap Bar)
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream And .soap. For Jock Itch Kit
FDA Label NDC 85398-022
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 Kit Antifungal Cream And .soap. For Jock Itch (NDC 85398-022). 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 - when using, otc - stop use, otc - do not 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
- For effective treatment of most athlete's foot, ringworm and jock itch.
- For effective relief of itching, burning and cracking skin.
Warnings
For external use only.
Otc - When Using
Avoid contact with the eye
Otc - Stop Use
iritationoccurs or if the is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.
Otc - Do Not Use
on children under 2 of age except under the advice and supervision of a doctor.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Cream:
- clean the affected area and dry thoroughly.
- apply a thin layer of the product over 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 the 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.
- this product is not effective on the scalp or nails
- Wash affected area well and let product sit 2-3 minutes before rinsing.
- Make sure to dry affected area thoroughly.
- Supervise children in the use of this product.
- For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
- Use 1-2 times daily. Use dailyfor 4 weeks; if condition persists longer, ask a doctor.
- This product is not effective on the scalp or nails.
Soap Bar:
Other Safety Information
Store at room temperature 59°-86°F (15°-30°C).
Inactive Ingredient
Cream:
Water, Smilax Glabra Root Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia Scoparia Fruit Extract, Pseudolarix Amabilis Bark Extract, Dictamnus Dasycarpus Root Bark Extract, Stemona Tuberosa Root Extract, Mentha Arvensis Leaf ERract, Glycyrrhetinic Acid
Soap Bar:
Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water, Glycerin, Butyrospermum Parki(Shea) Butter, Lauric Acid, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice, CocosNucifera (Coconut) Oil, Fragrance
Otc - Questions
visit us at
www.hermonhealth.com
Tel:
573-476-4179
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