CLOTRIMAZOLE ANTIFUNGAL TREATMENT KIT- clotrimazole 1% kit

Clotrimazole antifungal treatment kit by

Drug Labeling and Warnings

Clotrimazole antifungal 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

Clotrimazole 1%

PURPOSE

Antifungal

DOSAGE & ADMINISTRATION

Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tineacorporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

WARNINGS

For external use only.

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

avoide contact with eyes, lf contact occurs, rinse thoroughly with water.

irritation occurs or if there is no improvement within 2 weeks.

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

INDICATIONS & USAGE

For cream

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

For soap

• Wet skin with warm water and lather soap.
• Gently massage onto affected areas.
• Rinse thoroughly and dry.
• Use twice daily or as directed by a doctor.

INACTIVE INGREDIENT

For cream:

Purifed Water, White Petrolatum, Mineral Oil, Glycerol, Cetostearyl Alcohol, Glyceryl Mono-And Distearate, Dimethyl sulfoxide, Alcohol, Polyoxyethylene Lauryl Ether (Peregal 0), Edetate Disodium, Butylated Hydroxytoluene, Ethylparaben

For soap:

Melaleuca Alternifalla (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Olil, Cocos Nucifera (Coconut) Olil,Olea Europaea (0live) Fruit Oi, Propylene Glycol, Glycerin, stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (WitchHazel)Extract, Ceramide

STORAGE AND HANDLING

Store at room temperature. Protect from excessive heat (above 104°F/ 40°C)

QUESTIONS

visit us at www.hermonhealth.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE ANTIFUNGAL TREATMENT KIT 
clotrimazole 1% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85398-012

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-012-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	08/31/2025

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

Part 1 of 2

HERMON CLOTRIMAZOLE ANTIFUNGAL TREATMENT CREAM 
clotrimazole 1% cream

Product Information
Item Code (Source)	NDC: 85398-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	0.57 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85398-010-01	57 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	08/31/2025

Part 2 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
MYRISTIC ACID (UNII: 0I3V7S25AW)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ELAEIS GUINEENSIS (PALM) OIL (UNII: 5QUO05548Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURIC ACID (UNII: 1160N9NU9U)
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER (UNII: 8FP93ED6H2)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
AQUA (UNII: 059QF0KO0R)
SODIUM GLUTAMATE (UNII: W81N5U6R6U)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITOL (UNII: 506T60A25R)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
CERAMIDE 1 (UNII: 5THT33P7X7)

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	08/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/31/2025

Labeler - Beautivity LLC (096573788)

Registrant - Beautivity LLC (096573788)