FDA.reportPublic FDA data

Hermon Balanitis Cream

Manufacturer
Beautivity LLC
Effective date
2025-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:13:41

Label at a glance#

ProductHermon Balanitis Cream
Active ingredientSULFUR, SYMPHYTUM OFFICINALE WHOLE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

  • Antifungal. itch relief
  • Helps relieve inflammation and irritation

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 a doctor

OTC - WHEN USING SECTION

avoid contact with the eves. lf 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

  • 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.

INACTIVE INGREDIENT SECTION

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.

OTHER SAFETY INFORMATION

Store at 59-86°F(15-30°C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-013-01Hermon Balanitis Cream58 g in 1 BOTTLECREAM581

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-01385398-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
ALLANTOIN344S277G0ZIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
SORBITAN OLIVATEMDL271E3GRIACT
ZINC OXIDESOI2LOH54ZIACT
SILVER PARTICLE (10 MICRON)Q3A5NLA4B5IACT
SQUALANEGW89575KF9IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHOLL7T10EIP3AIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
GLYCERINPDC6A3C0OXIACT
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 318YWT2KYS8IACT
CHRYSANTHELLUM INDICUM TOPSTJ856D1Z0IACT
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YACTIB
CETEARYL ALCOHOL2DMT128M1SIACT
CETEARYL OLIVATE58B69Q84JOIACT
LITHOSPERMUM ERYTHRORHIZON ROOT9I70D8O47IIACT
SILVER3M4G523W1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CURCUMA LONGA (TURMERIC) ROOT856YO1Z64FIACT
SODIUM HYALURONATEYSE9PPT4THIACT
CHLORHEXIDINE ACETATE5908ZUF22YIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
HONEYY9H1V576FHIACT
CERAMIDE NP4370DF050BIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hermon Balanitis relief kitSULFUR 1X HPUSBeautivity LLC3dce086e-a4eb-4b21-e063-6394a90aa1b22025-09-02WarningsExact identifier
ndc (package): 85398-013-01
ndc11 (package): 85398001301
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
spl id: 3dba4e4b-8225-6a96-e063-6394a90a9129
spl set id: 3dba4e4b-8224-6a96-e063-6394a90a9129

Reported adverse events (FAERS/openFDA)#

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