Miconi-AL by True Marker Pharmaceuticals, Inc. Drug Facts

Miconi-AL by

Drug Labeling and Warnings

Miconi-AL by is a Otc medication manufactured, distributed, or labeled by True Marker Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MICONI-AL- miconazole nitrate liquid 
True Marker Pharmaceuticals, Inc.

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Drug Facts

Active Ingredient (s)

Miconazole Nitrate 2%

Purpose

Topical Antifungal

Uses

• Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm)
• For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
• Prevents most tinea pedis (athlete’s foot) with daily use.

Warnings

• For external use only
• Do Not Use– On children under 2 years of age unless directed by a doctor.
• When using this product, avoid contact with eyes.
• Stop use and ask a doctor, if irritation occurs of if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch)
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• If pregnant or breast-feeding, ask a health professional before use.

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
• Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• 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
• If condition persists longer, consult a doctor
• This product is not effective on the scalp or nails.

Other information

Protect the product in this container from excessive heat and direact sun

Inactive Ingredients

Helianthus annuus flowering top, Vitis Vinifera Fruit Oil, Peppermint, Alpha-Tocopherol Acetate, Butylated Hydroxytoluene.

QUESTIONS? 602-887-9879

Product label

MICONI-AL 
miconazole nitrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83592-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)
PEPPERMINT (UNII: V95R5KMY2B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83592-580-30	1 in 1 CARTON	10/17/2023	12/01/2024
1		30 mL in 1 BOTTLE, GLASS; 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	10/17/2023	12/01/2024

Labeler - True Marker Pharmaceuticals, Inc. (119046582)

Revised: 11/2024

Document Id: 27eb5e22-646b-1721-e063-6394a90af638

34390-5

Set id: e2ae2c19-bd4c-4638-843d-47eefa07dd12

Version: 3

Effective Time: 20241127