Label: MICONI-AL- miconazole nitrate liquid
- NDC Code(s): 83592-580-30
- Packager: True Marker Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (s)
- Purpose
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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.
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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.
- KEEP OUT OF REACH OF CHILDREN
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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
- Inactive Ingredients
- QUESTIONS? 602-887-9879
- Product label
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INGREDIENTS AND APPEARANCE
MICONI-AL
miconazole nitrate liquidProduct 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 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 Labeler - True Marker Pharmaceuticals, Inc. (119046582)