Hermon Balanitis relief kit

Manufacturer
Beautivity LLC
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:00

Label at a glance#

ProductHermon Balanitis relief kit
Active ingredientCLOTRIMAZOLE, SYMPHYTUM OFFICINALE WHOLE, SULFUR
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

  • Antifungal, itch relief.
  • Helps relieve inflammation and irritation
  • Antifungal

DOSAGE & ADMINISTRATION SECTION

Helps relieve redness, itching, and irritation from balanitis, and soothes discomfort from other
fungus-related skin conditions in sensitive areas.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

children under 2 years of age unless directed by adoctor.

OTC - WHEN USING SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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.

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN1
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD1
251267clotrimazole 1 % Medicated Bar SoapSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-011-01Hermon Balanitis relief kit116 g in 1 CARTONSOAP1 g in 1161.16 g in 116g1
85398-013-01Hermon Balanitis relief kit58 g in 1 BOTTLECREAM58 g1 [hp_X] in 58g1
85398-014-01Hermon Balanitis relief kit1 in 1 CARTONKIT11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-01485398-014-01
85398-01185398-011-01
85398-01385398-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
ndc (package): 85398-011-01
ndc (product): 85398-011
ndc11 (package): 85398001101
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
ndc (package): 85398-011-01
ndc11 (package): 85398001101
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
ndc (package): 85398-013-01
ndc (package): 85398-011-01
ndc (package): 85398-014-01
ndc (product): 85398-014
ndc11 (package): 85398001401
ndc11 (package): 85398001301
ndc11 (package): 85398001101
spl id: 3dce086e-a4ec-4b21-e063-6394a90aa1b2
spl set id: 3dce086e-a4eb-4b21-e063-6394a90aa1b2
Hermon Balanitis CreamSULFUR 1X HPUSBeautivity LLC3dba4e4b-8224-6a96-e063-6394a90a91292025-09-01WarningsExact identifier
ndc (package): 85398-013-01
ndc (product): 85398-013
ndc11 (package): 85398001301

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.