Initial Drug Listing - Hermon Balanitis Relief Kit

Initial Drug Listing - Hermon Balanitis Relief Kit
SPL v1
SPL
SPL Set ID 3dce086e-a4eb-4b21-e063-6394a90aa1b2
Route
TOPICAL
Published
Effective Date 2025-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1.16 g) Symphytum Officinale Whole (1 [hp_X]) Sulfur
Inactive Ingredients
Lauric Acid Myristic Acid Ceramide 1 Olea Europaea (olive) Fruit Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Glycerin Cocos Nucifera (coconut) Oil Elaeis Guineensis (palm) Oil Stearic Acid Sodium Dodecylbenzenesulfonate Sodium Myristate Water Sorbitol Sodium Hydroxide Propylene Glycol Sodium Glutamate Hamamelis Virginiana (witch Hazel) Leaf Water Sorbitan Olivate Alpha-tocopherol Acetate Transforming Growth Factor Beta Receptor Type 3 Curcuma Longa (turmeric) Root Cetearyl Alcohol Sodium Hyaluronate Chlorhexidine Acetate Camellia Sinensis Leaf Silver Butyrospermum Parkii (shea) Butter Squalane Simmondsia Chinensis (jojoba) Seed Oil Zinc Oxide 1,2-hexanediol Menthol Honey Lavandula Angustifolia (lavender) Oil Cetearyl Olivate Lithospermum Erythrorhizon Root Ceramide Np Allantoin Centella Asiatica Triterpenoids Silver Particle (10 Micron) Chrysanthellum Indicum Top Hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-17

Description

Sulfur 1X HPUS (cream) Symphytum Officinale (Comfrey) 1X HPUS (Cream) Clotrimazole 1%(Soap Bar)


Medication Information

Warnings and Precautions

For external use only

Indications and 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.



For Soap Bar:

  • 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.
Dosage and Administration

Helps relieve redness, itching, and irritation from balanitis, and soothes discomfort from other

fungus-related skin conditions in sensitive areas.

Description

Sulfur 1X HPUS (cream) Symphytum Officinale (Comfrey) 1X HPUS (Cream) Clotrimazole 1%(Soap Bar)

Section 50565-1

lf swallowed,get medical help or contact a Poison Control Center right away.

Section 50567-7

avoid contact with the eyes. if contact occurs, rinse the eyes very thoroughly with water.

Section 50569-3

if irritation occurs, symptoms persist for more than 2 weeks, or symptoms worsen after initial improvement

Section 50570-1

children under 2 years of age unless directed by adoctor.

Section 51727-6

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.

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1
  • Antifungal, itch relief.
  • Helps relieve inflammation and irritation
  • Antifungal
Section 55106-9
  • Sulfur 1X HPUS (cream)
  • Symphytum Officinale (Comfrey) 1X HPUS (Cream)
  • Clotrimazole 1%(Soap Bar)
Section 60561-8

store at 59-86°F(15-30°C)


Structured Label Content

Indications and Usage (34067-9)

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.



For Soap Bar:

  • 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.
Dosage and Administration (34068-7)

Helps relieve redness, itching, and irritation from balanitis, and soothes discomfort from other

fungus-related skin conditions in sensitive areas.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

lf swallowed,get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

avoid contact with the eyes. if contact occurs, rinse the eyes very thoroughly with water.

Section 50569-3 (50569-3)

if irritation occurs, symptoms persist for more than 2 weeks, or symptoms worsen after initial improvement

Section 50570-1 (50570-1)

children under 2 years of age unless directed by adoctor.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

visit us at www.hermonhealth.com

Section 55105-1 (55105-1)
  • Antifungal, itch relief.
  • Helps relieve inflammation and irritation
  • Antifungal
Section 55106-9 (55106-9)
  • Sulfur 1X HPUS (cream)
  • Symphytum Officinale (Comfrey) 1X HPUS (Cream)
  • Clotrimazole 1%(Soap Bar)
Section 60561-8 (60561-8)

store at 59-86°F(15-30°C)


Advanced Ingredient Data


Raw Label Data

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