HERMON BALANITIS CREAM- sulfur 1x hpus cream

Hermon Balanitis Cream by

Drug Labeling and Warnings

Hermon Balanitis Cream by is a Otc medication manufactured, distributed, or labeled by Beautivity LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

• Antifungal. itch relief
• Helps relieve inflammation and irritation

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

children under 2 years of age unless directed by a doctor

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

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

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

INDICATIONS & 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.

INACTIVE INGREDIENT

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)

QUESTIONS

visit us at www.hermonhealth.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HERMON BALANITIS CREAM 
sulfur 1x hpus cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85398-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1 [hp_X]  in 58 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	1 [hp_X]  in 58 g

Inactive Ingredients
Ingredient Name	Strength
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
ALLANTOIN (UNII: 344S277G0Z)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ZINC OXIDE (UNII: SOI2LOH54Z)
SILVER PARTICLE (10 MICRON) (UNII: Q3A5NLA4B5)
SQUALANE (UNII: GW89575KF9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MENTHOL (UNII: L7T10EIP3A)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
LITHOSPERMUM ERYTHRORHIZON ROOT (UNII: 9I70D8O47I)
SILVER (UNII: 3M4G523W1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CURCUMA LONGA (TURMERIC) ROOT (UNII: 856YO1Z64F)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
HONEY (UNII: Y9H1V576FH)
CERAMIDE NP (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-013-01	58 g in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/15/2025

Labeler - Beautivity LLC (096573788)

Registrant - Beautivity LLC (096573788)