36eb334e-246b-249f-e063-6294a90ab811
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient : Miconazole Nitrate 2%
Medication Information
Warnings and Precautions
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 and Usage
Uses
■ Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Dosage and 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.
Description
Active Ingredient : Miconazole Nitrate 2%
Section 50565-1
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.
Section 51727-6
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
Section 51945-4
Section 55105-1
Purpose…………………………………….. Antifungal
Section 55106-9
Active Ingredient: Miconazole Nitrate 2%
Structured Label Content
Indications and Usage (34067-9)
Uses
■ Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Dosage and Administration (34068-7)
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 and Precautions (34071-1)
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.
Section 50565-1 (50565-1)
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.
Section 51727-6 (51727-6)
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
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose…………………………………….. Antifungal
Section 55106-9 (55106-9)
Active Ingredient: Miconazole Nitrate 2%
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Source: dailymed · Ingested: 2026-02-15T12:06:15.239604 · Updated: 2026-03-14T23:08:56.104871