FUNGUS MASTER- miconazole nitrate lotion

Fungus Master by

Drug Labeling and Warnings

Fungus Master by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Miconazole Nitrate 2%

DOSAGE & ADMINISTRATION

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

WARNINGS

Warnings

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

■ For external use only.

■ Avoid contact with the eyes.

■ If irritation occurs or if there is no improvement within 4 weeks for the treatment of athlete's foot and ringworm, or 2 weeks for the treatment of jock itch, discontinue use and consult a doctor.

INDICATIONS & USAGE

Uses

■ Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

KEEP OUT OF REACH OF CHILDREN

Other Information

■ Shake well before use.

■ Keep away from direct sunlight or heat. Store at room temperature 15°-30°C (59°-86°F).

■ Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

INACTIVE INGREDIENT

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine HCl, Ascorbyl Palmitate, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetearyl Alcohol, Cinnamomum Zeylanicum Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Cymbopogon Flexuosus Oil, Dimethyl Isosorbide, Disodium EDTA, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Fusanus Spicatus Wood (Sandalwood) Oil, Glycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Leptospermum Scoparium Branch/Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Origanum Vulgare (Oregano) Leaf Oil, Panthenol, PEG-12 Dimethicone, PEG-4 Dilaurate, PEG-40 Hydrogenated Castor Oil, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phospholipids, Polysorbate 20, Polysorbate 60, PPG-26-Buteth-26, Retinyl Palmitate, Salicylic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Bicarbonate, Squalane, Tocopheryl Acetate, Triethanolamine, Undecylenic Acid, Urea, Water, Xanthan Gum

PURPOSE

Purpose…………………………………….. Antifungal

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGUS MASTER 
miconazole nitrate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
UREA (UNII: 8W8T17847W)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL (UNII: AKN3KSD11B)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OIL (UNII: M6QU9ZUH2X)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CYMBOPOGON FLEXUOSUS OIL (UNII: UP0M8M3VZW)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
CINNAMOMUM ZEYLANICUM LEAF OIL (UNII: S92U8SQ71V)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL (UNII: 578389D6D0)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
ORIGANUM VULGARE LEAF OIL (UNII: 7D0CGR40U1)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
FUSANUS SPICATUS WOOD OIL (UNII: H9LVS6REV4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
PEG-4 DILAURATE (UNII: KCR71CW036)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
XANTHAN GUM (UNII: TTV12P4NEE)
PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1)
SQUALANE (UNII: GW89575KF9)
RETINYL PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
DODECANE (UNII: 11A386X1QH)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (Yellowish offwhite)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-098-01	30 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/06/2025
2	NDC: 63742-098-02	59 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/06/2025

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Registrant - Clinical Resolution Laboratory, Inc. (825047942)

Establishment
Name	Address	ID/FEI	Business Operations
Clinical Resolution Laboratory, Inc.		825047942	manufacture(63742-098)