Budpak Antifungal Miconazole Nitrate
FDA Label NDC 27293-023

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Budpak Inc. for the product Budpak Antifungal Miconazole Nitrate (NDC 27293-023). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Miconazole Nitrate 2.0%

Otc - Purpose

Purpose

Antifungal

Indications & Usage

Uses

  • cures most athlete's foot, jock itch, and ringworm.
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warnings

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

Otc - When Using

When using this product avoid contact with eyes.

Otc - Stop Use

Stop using this product and ask a doctor

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
  • do not use for diaper rash

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children.

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

Dosage & Administration

Directions

  • 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, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day

  • 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.

Other

Other information

  • Store between 15°C to 30° C (59°F to 86° F)
  • Lot No. & Exp. Date: see crimp of tube.

    • PRINCIPAL DISPLAY PANEL

    Budpak Antifungal Cream

    Miconazole Nitrate 2%

    Antifungal for Athlete’s Foot and Jock Itch

    NET WT 0.5 OZ (14 g)

Inactive Ingredient

Inactive Ingredients

Benzoic Acid, Butylated Hydroxy Anisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

Package Label.Principal Display Panel

Image Of Package Label (Miconazole)

Image Of Package Label (Miconazole)

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