Baza Antifungal Cream
FDA Label NDC 11701-045

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Corp for the product Baza Antifungal (NDC 11701-045). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

For Perineal
Skin Irritation Due to
Fungal Infection

Drug Facts

For external use only.

Otc - Active Ingredient

Active ingredient

Miconazole Nitrate, 2%

Otc - Purpose

Purpose

Antifungal

Indications & Usage

Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.

Warnings

Warnings

Otc - When Using

When using this product

  • avoid contact with eyes
  • do not use on children under 2 years of age unless directed by a doctor.

Otc - Stop Use

Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks.

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

  • clean the affected area and dry thoroughly
  • apply thin layer of product over affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product.

    • Use daily for 2 weeks.

    If condition persists, consult a doctor. This product is not effective on scalp or nails.

Inactive Ingredient

Inactive ingredients

BHT, cetearth-6, cetyl alcohol, cod liver oil, diazolidinyl urea, fragrance, glyceryl stearate, lanolin oil, PEG-100 stearate, petrolatum, polmethoxybicyclic oxazolidine, propylene glycol, water, stearyl alcohol, tocopheryl acetate, zinc oxide

See crimp for lot no. and expiration date

Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com
Product #1607 ©2008-7, Coloplast Corp.
Made in the U.S.A.

G8-664

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142 g)

NDC 11701-045-14

Baza®Antifungal

Antifungal

Moisture Barrier Antifungal Cream

For Perineal Skin Irritation Due to Fungal Infection

Coloplast

NET WT. 5 OZ. (142 g)

Principal Display Panel (NET WT. 5 OZ. (142g))

Principal Display Panel (NET WT. 5 OZ. (142g))

* Please review the disclaimer below.