TINEA VERSICOLOR TREATMENT KIT- clotrimazole kit

Tinea Versicolor Treatment Kit by

Drug Labeling and Warnings

Tinea Versicolor Treatment Kit by is a Otc medication manufactured, distributed, or labeled by Beautivity LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cream: Clotrimazole 1%
Soap bar: Clotrimazole 1%

PURPOSE

Antifungal

INDICATIONS & USAGE

Helps relieve and prevent itching, burning, cracking, and scaling associated with tinea versicolor infections.

WARNINGS

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes, If contact occurs, rinse thoroughly with water.

Stop use and ask doctor if irritation occurs or if there is no improvement within 2 weeks.

keep out of reach of children. If swallowed, get medical help or contact a Posion Control enter right away.

DOSAGE & ADMINISTRATION

Wash the affected area & dry thoroughly.
Apply a thin layer over affected area twice daily (morning and night).
Supervise children in the use of this produt.
Use daily for 2 weeks.

INACTIVE INGREDIENT

Cream: Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil

Soap Bar: Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzenesulfonate, Sulfur, Hamamelis Virginiana Root Bark, Ceramide NP

STORAGE AND HANDLING

Store at room temperature. Protect from excessive heat (above 104ºF / 40ºC)

QUESTIONS

visit us at www.hermonhealth.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINEA VERSICOLOR TREATMENT KIT 
clotrimazole kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85398-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-004-01	1 in 1 KIT; Type 0: Not a Combination Product	05/15/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CARTON	116 g
Part 2	1 TUBE	60 g

Part 1 of 2

TINEA VERSICOLOR TREATMENT BAR 
clotrimazole soap

Product Information
Item Code (Source)	NDC: 85398-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
SORBITOL (UNII: 506T60A25R)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
MYRISTIC ACID (UNII: 0I3V7S25AW)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
ELAEIS GUINEENSIS (PALM) OIL (UNII: 5QUO05548Z)
LAURIC ACID (UNII: 1160N9NU9U)
SULFUR (UNII: 70FD1KFU70)
CERAMIDE NP (UNII: 4370DF050B)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM GLUTAMATE (UNII: W81N5U6R6U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-003-01	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	05/15/2025

Part 2 of 2

TINEA VERSICOLOR TREATMENT CREAM 
clotrimazole cream

Product Information
Item Code (Source)	NDC: 85398-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
TROLAMINE (UNII: 9O3K93S3TK)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-002-01	60 g in 1 TUBE; 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	05/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/15/2025

Labeler - Beautivity LLC (096573788)