FUNGUS MASTER FUNGAL TREATMENT- miconazole nitrate lotion

Fungus Master Antifungal Treatment by

Drug Labeling and Warnings

Fungus Master Antifungal Treatment by is a Otc medication manufactured, distributed, or labeled by Ebanel Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

• Proven clinically effective in the treatment of most athlete’s foot, jock itch and ringworm.
• For effective relief of itching, scaling, cracking, burning, redness, irritation and discomfort.

Warnings

• Do not use on children under 2 years of age.
• For external use only.
• Avoid contact with the eyes.
• If irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

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:

INGREDIENTS AND APPEARANCE

FUNGUS MASTER FUNGAL TREATMENT 
miconazole nitrate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72654-001
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 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72654-001-01	30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	11/01/2019
2	NDC: 72654-001-02	59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/01/2019

Labeler - Ebanel Laboratories, Inc (079352161)