FUNGUS MASTER ANTIFUNGAL TREATMENT- miconazole nitrate lotion 
Ebanel Laboratories, Inc

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Fungus Master Antifungal Treatment

DRUG FACTS

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

Keep out of reach of children.

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

Directions

Wash 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. Store at 15-30°C (59-86°F)

Other Information

Functional ingredients used in this formula have been shown to improve the appearance of thickened, discolored, and unhealthylooking feet caused by dermatophytic fungi. Urea has been shown to thin, soften, and act as penetrating agent on skin. Undecylenic acid is effective as an emulsifier, cleanser, and preservative.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cinnamomum Zeylanicum Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Cymbopogon Flexuosus Oil, Dimethyl Isosorbide, Dodecane, Eucalyptus Globulus Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Glycerin, Lavandula Angustifolia (Lavender) Flower Oil, Leptospermum Scoparium Branch/Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Oreganum Vulgare Leaf Oil, Panthenol, PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, PEG-8 Dilaurate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Phospholipids, Polysorbate 20, Polysorbate 60, PPG-26-Buteth-26, Punica Granatum Seed Extract, Retinyl Palmitate, Salicylic Acid, Santalum Spicatum Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Bicarbonate,Tocopheryl Acetate,Undecylenic Acid, Inact ive Ingredients Urea, Water

Package Labeling:

123

FUNGUS MASTER ANTIFUNGAL TREATMENT 
miconazole nitrate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72654-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ARGININE (UNII: 94ZLA3W45F)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
ORANGE OIL (UNII: AKN3KSD11B)  
COCONUT OIL (UNII: Q9L0O73W7L)  
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
DODECANE (UNII: 11A386X1QH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CLOVE OIL (UNII: 578389D6D0)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANUKA OIL (UNII: M6QU9ZUH2X)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PEG-8 DILAURATE (UNII: FC11NGP7E6)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
POMEGRANATE SEED (UNII: 7294Z34NS7)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
JOJOBA OIL (UNII: 724GKU717M)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UNDECYLENIC ACID (UNII: K3D86KJ24N)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72654-001-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product11/01/2019
2NDC:72654-001-0259 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00511/01/2019
Labeler - Ebanel Laboratories, Inc (079352161)

Revised: 12/2023
Document Id: 0d771f4d-fd0d-cd5d-e063-6394a90a0720
Set id: f7b011b2-11e5-46f1-afed-89f438985e00
Version: 5
Effective Time: 20231226
 
Ebanel Laboratories, Inc