HERMON BALANITIS RELIEF KIT- sulfur 1x hpus kit

Hermon Balanitis relief kit by

Drug Labeling and Warnings

Hermon Balanitis relief kit 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 (cream)
• Symphytum Officinale (Comfrey) 1X HPUS (Cream)
• Clotrimazole 1%(Soap Bar)

PURPOSE

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

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 adoctor.

avoid contact with the eyes. if 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

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

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)

QUESTIONS

visit us at www.hermonhealth.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HERMON BALANITIS RELIEF KIT 
sulfur 1x hpus kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85398-014

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-014-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	09/17/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 CARTON	1 g  in 116
Part 2	1 BOTTLE	58 g

Part 1 of 2

HERMON CLOTRIMAZOLE ANTIFUNGAL SOAP. BAR 
clotrimazole 1% soap

Product Information
Item Code (Source)	NDC: 85398-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1.16 g  in 116 g

Inactive Ingredients
Ingredient Name	Strength
LAURIC ACID (UNII: 1160N9NU9U)
MYRISTIC ACID (UNII: 0I3V7S25AW)
CERAMIDE 1 (UNII: 5THT33P7X7)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
ELAEIS GUINEENSIS (PALM) OIL (UNII: 5QUO05548Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM GLUTAMATE (UNII: W81N5U6R6U)
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER (UNII: 8FP93ED6H2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-011-01	116 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/17/2025

Part 2 of 2

HERMON BALANITIS CREAM 
sulfur 1x hpus cream

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

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/17/2025

Labeler - Beautivity LLC (096573788)

Registrant - Beautivity LLC (096573788)