84558-013

84558-013
SPL v1
SPL
SPL Set ID 40c491f6-43b4-534e-e063-6294a90a73d6
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Aqua Urea Glycerin Propylene Glycol Cetearyl Alcohol Ethylhexyl Palmitate Caprylic/capric Triglyceride Dimethicone C14-22 Alcohols Betaine Trehalose Butyrospermum Parkii (shea) Butter Cocos Nucifera (coconut) Oil Dextrin, Corn Panthenol Phenoxyethanol Potassium Cetyl Phosphate C12-20 Alkyl Glucoside Salicylic Acid Hydroxyacetophenone Allantoin Carbomer Centella Asiatica Triterpenoids Propanediol Melaleuca Alternifolia (tea Tree) Leaf Oil Menthol Butylene Glycol Triethanolamine O-cymen-5-ol Polysorbate 80 Clove Chlorphenesin Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Xanthan Gum Sophora Flavescens Root Chamomile Polyglyceryl-2 Isostearate Madecassoside Isohexadecane Alpha-tocopherol Acetate Gentiana Scabra Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-10

Description

MICONAZOLE NITRATE 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

MICONAZOLE NITRATE 2%

Use

Uses: Treats skin fungal infections: jock itch (tinea cruris), athlete's foot

(tinea pedis), ringworm (tinea corporis).Relieves itching, redness,

burning, and irritation from fungal infections. Soothes skin and sup-

ports recovery in moisture/friction-prone areas (groin, inner thighs,

body folds)

Section 50565-1

Children Under 12: Consult a doctor before use.

Section 50566-9

Stop use & ask a doctor if: iritation/rash develops; condition wors-

ens or no improvement within 2 weeks. If pregnant or breastfeeding, ask

a healthcare professional before use. Keep out of reach of children. If

swallowed, get medical help or contact a Poison Control Center imme-

diately.

Section 50567-7

When using this product: Avoid contact with eyes. If contact occurs,

rinse thoroughly with water.

Warnings

Warnings: For external use only.

Directions

Directions: Adults & Children 12+; Clean and dry the affected area

thoroughly; Apply a thin layer of cream twice daily (morning & night);

Continue use for up to 2 weeks, or as directed by a doctor; Wear

loose-fitting clothing to keep the area dry

Do Not Use

Do not use: on broken, iflamed, or severely rritated skin; or if allergic

to Miconazole Nitrate/any ingredients.

Other Information

Other Information: Store between 20° -27°C (68° -81°F); See top panel

for lot number and expiration date

Active Ingredient(s)

MICONAZOLE NITRATE 2%

Inactive Ingredients

Aqua, Urea, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ethylhexyl Palmitate,

Caprylic/Capric Triglyceride, Dimethicone, C14- 22 Alcohols, Betaine, Trehalose,

Butyrospermum Parki (Shea) Butter, Cocos Nucifera (Coconut) Oil, Dextrin, Panthenol,

Phenoxyethanol, Potassium Cetyl Phosphate, C12 - 20 Alkyl Glucoside, Salicylic Acid,

Hydroxyacetophenone, Allantoin, Carbomer, Tocopheryl Acetate, Triethanolamine,

Melaleuca Alternifolia (Tea Tree) Leaf oil, Polysorbate 80 Mentholum, Butylene Glycol,

Propanediol, Xanthan Gum, 0- Cymene-5- Ol, Fragrance, Sodium Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Polycarbamy-2 Isostearate, Chlorphenesin,

Pentaerythrityl Tetra- Di-T-Butyl Hydroxyhydrocinnamate, lsohexadecane,

Macadamiaside, Glyrhiza Inflata Extract, Centella Asiatica Extract, Sesame Amino

Acids, Gentiana Scabra Root Extract, Sophora Flavescens Extract, Chamomilla Recutita

(Matricaria) Flower Extract, Sophora Angustifolia Root Extract.

Package Label Principal Display Panel


Structured Label Content

Use

Uses: Treats skin fungal infections: jock itch (tinea cruris), athlete's foot

(tinea pedis), ringworm (tinea corporis).Relieves itching, redness,

burning, and irritation from fungal infections. Soothes skin and sup-

ports recovery in moisture/friction-prone areas (groin, inner thighs,

body folds)

Section 50565-1 (50565-1)

Children Under 12: Consult a doctor before use.

Section 50566-9 (50566-9)

Stop use & ask a doctor if: iritation/rash develops; condition wors-

ens or no improvement within 2 weeks. If pregnant or breastfeeding, ask

a healthcare professional before use. Keep out of reach of children. If

swallowed, get medical help or contact a Poison Control Center imme-

diately.

Section 50567-7 (50567-7)

When using this product: Avoid contact with eyes. If contact occurs,

rinse thoroughly with water.

Purpose

Antifungal

Warnings

Warnings: For external use only.

Directions

Directions: Adults & Children 12+; Clean and dry the affected area

thoroughly; Apply a thin layer of cream twice daily (morning & night);

Continue use for up to 2 weeks, or as directed by a doctor; Wear

loose-fitting clothing to keep the area dry

Do Not Use (Do not use)

Do not use: on broken, iflamed, or severely rritated skin; or if allergic

to Miconazole Nitrate/any ingredients.

Other Information (Other information)

Other Information: Store between 20° -27°C (68° -81°F); See top panel

for lot number and expiration date

Active Ingredient(s)

MICONAZOLE NITRATE 2%

Inactive Ingredients (Inactive ingredients)

Aqua, Urea, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ethylhexyl Palmitate,

Caprylic/Capric Triglyceride, Dimethicone, C14- 22 Alcohols, Betaine, Trehalose,

Butyrospermum Parki (Shea) Butter, Cocos Nucifera (Coconut) Oil, Dextrin, Panthenol,

Phenoxyethanol, Potassium Cetyl Phosphate, C12 - 20 Alkyl Glucoside, Salicylic Acid,

Hydroxyacetophenone, Allantoin, Carbomer, Tocopheryl Acetate, Triethanolamine,

Melaleuca Alternifolia (Tea Tree) Leaf oil, Polysorbate 80 Mentholum, Butylene Glycol,

Propanediol, Xanthan Gum, 0- Cymene-5- Ol, Fragrance, Sodium Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Polycarbamy-2 Isostearate, Chlorphenesin,

Pentaerythrityl Tetra- Di-T-Butyl Hydroxyhydrocinnamate, lsohexadecane,

Macadamiaside, Glyrhiza Inflata Extract, Centella Asiatica Extract, Sesame Amino

Acids, Gentiana Scabra Root Extract, Sophora Flavescens Extract, Chamomilla Recutita

(Matricaria) Flower Extract, Sophora Angustifolia Root Extract.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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