SPL v1
SPL
SPL Set ID 36eb334e-246b-249f-e063-6294a90ab811
Route
TOPICAL
Published
Effective Date 2025-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Mentha Piperita (peppermint) Oil Panthenol Peg-12 Dimethicone Urea Peg-40 Hydrogenated Castor Oil Caprylyl Glycol Citrus Aurantium Dulcis (orange) Peel Oil Dimethyl Isosorbide Polysorbate 60 Melaleuca Alternifolia (tea Tree) Leaf Oil Triethanolamine Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Phenoxyethanol Hexylene Glycol Leptospermum Scoparium Branch/leaf Oil Butyrospermum Parkii (shea) Butter Cymbopogon Flexuosus Oil Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Undecylenic Acid Cinnamomum Zeylanicum Leaf Oil Simmondsia Chinensis (jojoba) Seed Oil Sodium Bicarbonate Glycerin Eugenia Caryophyllus (clove) Bud Oil Cocos Nucifera (coconut) Oil Origanum Vulgare Leaf Oil Disodium Edta-copper Polysorbate 20 Lavandula Angustifolia (lavender) Oil Fusanus Spicatus Wood Oil Sodium Benzoate Ppg-26-buteth-26 Peg-4 Dilaurate Salicylic Acid Cetearyl Alcohol Arginine Hydrochloride Ethylhexylglycerin Eucalyptus Oil Xanthan Gum Persea Gratissima (avocado) Oil Squalane Retinyl Palmitate Ascorbyl Palmitate .alpha.-tocopherol Acetate, D- Dodecane Egg Phospholipids Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-06

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%


Advanced Ingredient Data


Raw Label Data

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