Initial Drug Listing - Hermon Balanitis Cream

Initial Drug Listing - Hermon Balanitis Cream
SPL v1
SPL
SPL Set ID 3dba4e4b-8224-6a96-e063-6394a90a9129
Route
TOPICAL
Published
Effective Date 2025-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (1 [hp_X]) Symphytum Officinale Whole
Inactive Ingredients
Butyrospermum Parkii (shea) Butter Allantoin Lavandula Angustifolia (lavender) Oil Water Sorbitan Olivate Zinc Oxide Silver Particle (10 Micron) Squalane 1,2-hexanediol .alpha.-tocopherol Acetate Menthol Simmondsia Chinensis (jojoba) Seed Oil Glycerin Transforming Growth Factor Beta Receptor Type 3 Chrysanthellum Indicum Top Cetearyl Alcohol Cetearyl Olivate Lithospermum Erythrorhizon Root Silver Hydroxyacetophenone Camellia Sinensis Leaf Curcuma Longa (turmeric) Root Sodium Hyaluronate Chlorhexidine Acetate Centella Asiatica Triterpenoids Honey Ceramide Np

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15
Description

Sulfur 1X HPUS Symphytum Officinale (Comfrey) 1X HPUS

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • 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.
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 Symphytum Officinale (Comfrey) 1X HPUS

Section 50565-1

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

Section 50567-7

avoid contact with the eves. lf 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 a doctor

Section 51727-6

Water (Aqua), Simmondsia Chinensis (jojoba) Seed Oil, Glycerin, Squalane, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Butter, Lithospermum Erythrorhizon Root Extract, Zinc Oxide, Silver, Allantoin, Centella Asiatica Extract, Beta-Glucan, Chrysanthelum Indicum Extract, Hydroxyace-tophenone, Honey Extract, 1,2-Hexanediol, Camelia Sinensis (Green Tea) Leaf Extract, Curcuma Longa(Turmeric) Root Extract, Microsilver BG, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Ceramide NP, Sodium Hyaluronate, Menthol, Chlorhexidine Acetate.

Section 51945-4

Section 53413-1

visit us at www.hermonhealth.com

Section 55105-1
  • Antifungal. itch relief
  • Helps relieve inflammation and irritation
Section 55106-9
  • Sulfur 1X HPUS
  • Symphytum Officinale (Comfrey) 1X HPUS
Section 60561-8

Store at 59-86°F(15-30°C)

Structured Label Content

Indications and Usage (34067-9)
  • 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.
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 eves. lf 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 a doctor

Section 51727-6 (51727-6)

Water (Aqua), Simmondsia Chinensis (jojoba) Seed Oil, Glycerin, Squalane, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Butter, Lithospermum Erythrorhizon Root Extract, Zinc Oxide, Silver, Allantoin, Centella Asiatica Extract, Beta-Glucan, Chrysanthelum Indicum Extract, Hydroxyace-tophenone, Honey Extract, 1,2-Hexanediol, Camelia Sinensis (Green Tea) Leaf Extract, Curcuma Longa(Turmeric) Root Extract, Microsilver BG, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Ceramide NP, Sodium Hyaluronate, Menthol, Chlorhexidine Acetate.

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
Section 55106-9 (55106-9)
  • Sulfur 1X HPUS
  • Symphytum Officinale (Comfrey) 1X HPUS
Section 60561-8 (60561-8)

Store at 59-86°F(15-30°C)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:00.163507 · Updated: 2026-03-14T23:10:09.220745