Update-85498-011-01

Update-85498-011-01
SPL v3
SPL
SPL Set ID 31f4b0eb-b8aa-7ccb-e063-6394a90ad981
Route
TOPICAL
Published
Effective Date 2025-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Glycerin Sodium Acryloyldimethyltaurate Dimethicone Propylene Glycol Isohexadecane Peppermint Oil Sodium Acrylate Polysorbate 80 Sophora Flavescens Root Triethanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-30

Description

Miconazole Nitrate 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • Relieves itching, burning, cracking, scaling, and discomfort caused by fungal infections.
Dosage and Administration
  • wash affected area and dry thoroughly.
  • apply a thin layer 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 and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
  • if conditions persist longer, ask a doctor.
  • this product is not effective on the scalp or nails.
Description

Miconazole Nitrate 2%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

and ask a doctor if

  • irritation occurs.
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch).
Section 50567-7

avoid contact with eyes.

Section 50569-3

before use if you have

  • a condition that covers a large area of the body
  • sensitive skin or any known allergies to the ingredients

Section 50570-1

on children under 2 years of age except under the advice and supervision of a doctor.

Section 51727-6

Sophora Flavescens Root, Glycerin, Propylene Glycol, Peppermint Oil, Sodium Acrylate, Sodium Acryloyldimethyl Taurate, Isohexadecane, Polysorbate-80, Dimethicone, Triethanolamine

Section 51945-4

Section 53413-1

Contact us at [email protected]

Section 53414-9

ask a health professional before use

Section 55105-1

Antifungal

Section 55106-9

Miconazole Nitrate 2%

Section 60561-8

Store at 20ºC to 25ºC (68ºF to 77ºF).

Close the cap tightly after use.


Structured Label Content

Indications and Usage (34067-9)
  • For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • Relieves itching, burning, cracking, scaling, and discomfort caused by fungal infections.
Dosage and Administration (34068-7)
  • wash affected area and dry thoroughly.
  • apply a thin layer 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 and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
  • if conditions persist longer, ask a doctor.
  • this product is not effective on the scalp or nails.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

and ask a doctor if

  • irritation occurs.
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch).
Section 50567-7 (50567-7)

avoid contact with eyes.

Section 50569-3 (50569-3)

before use if you have

  • a condition that covers a large area of the body
  • sensitive skin or any known allergies to the ingredients

Section 50570-1 (50570-1)

on children under 2 years of age except under the advice and supervision of a doctor.

Section 51727-6 (51727-6)

Sophora Flavescens Root, Glycerin, Propylene Glycol, Peppermint Oil, Sodium Acrylate, Sodium Acryloyldimethyl Taurate, Isohexadecane, Polysorbate-80, Dimethicone, Triethanolamine

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Contact us at [email protected]

Section 53414-9 (53414-9)

ask a health professional before use

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Miconazole Nitrate 2%

Section 60561-8 (60561-8)

Store at 20ºC to 25ºC (68ºF to 77ºF).

Close the cap tightly after use.


Advanced Ingredient Data


Raw Label Data

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