Otc - Active Ingredient
- Sulfur 1X HPUS (cream)
- Symphytum Officinale (Comfrey) 1X HPUS (Cream)
- Clotrimazole 1%(Soap Bar)
Hermon Balanitis Relief Kit
FDA Label NDC 85398-014
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 Balanitis Relief Kit (NDC 85398-014). 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 - ask doctor, 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, itch relief.
- Helps relieve inflammation and irritation
- Antifungal
Dosage & Administration
Helps relieve redness, itching, and irritation from balanitis, and soothes discomfort from other
fungus-related skin conditions in sensitive areas.
Warnings
For external use only
Otc - Do Not Use
children under 2 years of age unless directed by adoctor.
Otc - When Using
avoid contact with the eyes. if contact occurs, rinse the eyes very thoroughly with water.
Otc - Ask Doctor
if irritation occurs, symptoms persist for more than 2 weeks, or symptoms worsen after initial improvement
Otc - Keep Out Of Reach Of Children
lf swallowed,get medical help or contact a Poison Control Center right away.
Indications & Usage
For Cream:
- Apply a thin layer to clean, dry skin 1-2 times daily or as needed.
- For first-time users,test on a small patch of skin before full application.
- Massage gently until fully absorbed.
- For bestresults, use after cleansing with the antifungal soap.
- Wash affected area and dry thoroughly.
- Allow the lather to remain on skin for 1-2minutes before rinsing.
- Ensure the affected area is dried completely before applying cream.
- Use 1-2times daily or directed by doctor.
For Soap Bar:
Inactive Ingredient
Cream: Water (Aqua), Simmondsia chinensis (Jojoba) Seed Oil, Glycerin, Squalane, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Butyrospermum Parki (Shea) Butter, Lithospermum Erythrorhizon Root Extract, ZincOxide, Silver, Allantoin, Centella Asiatica Extract, Beta-Glucan, Chrysanthellum indicum Extract, Hydroxyace-tophenone, Honey Extract, 1,2-Hexanediol, Camellia Sinensis (Green Tea) Leaf Extract, Curcuma Longa(Turmeric) Root Extract, Microsilver BG", Tocopheryl Acetate, Lavandula Angustifolla (Lavender) Oil, CeramideNP, Sodium Hyaluronate, Menthol, Chlorhexidine Acetate.
Soap Bar: Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glvcol, Glycerin, Stearic Acid, Lauric Acid. Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate,Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide.
Other Safety Information
store at 59-86°F(15-30°C)
Otc - Questions
visit us at www.hermonhealth.com
Package Label.Principal Display Panel
Package (Package)
* Please review the disclaimer below.
