FUNGICURE NIGHT CREAM- clotrimazole cream

Fungicure Night Cream by

Drug Labeling and Warnings

Fungicure Night Cream by is a Otc medication manufactured, distributed, or labeled by Kobayashi Healthcare International, Inc., Kobayashi America Manufacturing, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

For the cure of most

• athlete's foot (tinea pedis)

For relief og:

• itching
• scaling
• cracking
• burning
• redness
• soreness
• irritation
• discomforts which may accompany this condition.

Warnings

For external use only.

Ask a doctor before use

on children under 2 years of age.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

• Clean the affected area and dry thoroughly.
• Apply a thin layer of FUNGICURE Night Cream over the affected area twice daily (morning and night), or as directed by a doctor.
• For athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
• For athlete's foot: Pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
• Supervise children in the use of this product.
• This product is not effective on scalp or nails.

Other information

• Fungicure Night Cream may be applied to exposed nail-beds, to cuticles, around nail edges and under nail tips.
• While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use Fungicure Night Cream until satisfactory results are obtained.
• This product is not intended to, nor will it, penetrate hard nail surfaces.
• Keep container tightly closed when not in use.
• Store away from excessive heat and cold.
• You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Aloe barbadensis leaf juice, cetyl alcohol, citric acid, dimethicone, disodium EDTA, D-panthenol, glycerin, glyceryl stearate, green tea extract, isopropyl myristate, licorice (glycyrrhiza glabra) root extract, petrolatum, phenoxyethanol, polysorbate 80, purified water, shea butter, sodium citrate, stearyl alcohol, tea tree (melaleuca alternifolia) oil, tocopheryl acetate, urea, willow (salix alba) bark extract, xanthan gum.

Questions?

1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGICURE NIGHT CREAM 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-681
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
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
TEA TREE OIL (UNII: VIF565UC2G)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)
WILLOW BARK (UNII: S883J9JDYX)
SHEA BUTTER (UNII: K49155WL9Y)
DISODIUM HEDTA (UNII: KME849MC7A)
PANTHENOL (UNII: WV9CM0O67Z)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-681-02	1 in 1 CARTON	12/19/2025
1		48.2 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	12/19/2025

Labeler - Kobayashi Healthcare International, Inc. (156391729)

Registrant - Kobayashi America Manufacturing, LLC (079852115)