Baza

Drug Facts

Composition & Product

Active Ingredients

Miconazole (20 mg)

Inactive Ingredients

Petrolatum Cetyl Alcohol Glyceryl Monostearate Butylated Hydroxytoluene Cod Liver Oil .alpha.-tocopherol Acetate, D- Lanolin Ceteareth-6 Stearyl Alcohol Propylene Glycol Peg-100 Stearate Zinc Oxide Diazolidinyl Urea Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-06-15

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and 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.

Description

For Perineal Skin Irritation Due to Fungal Infection

Section 42229-5

For Perineal

Skin Irritation Due to

Fungal Infection

Section 50565-1

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product

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

Section 51727-6

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

Section 51945-4

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)

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Miconazole Nitrate, 2%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

For Perineal

Skin Irritation Due to

Fungal Infection

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Miconazole Nitrate, 2%

Advanced Ingredient Data

[{"name": "MICONAZOLE", "unii": "7NNO0D7S5M", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COD LIVER OIL", "unii": "BBL281NWFG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETEARETH-6", "unii": "2RJS3559D3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.", "34068-7": "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.", "34071-1": "Warnings", "42229-5": "For Perineal Skin Irritation Due to Fungal Infection", "50565-1": "Keep this and all drugs out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks.", "50567-7": "When using this product avoid contact with eyes do not use on children under 2 years of age unless directed by a doctor.", "51727-6": "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", "51945-4": "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)", "55105-1": "Purpose Antifungal", "55106-9": "Active ingredient Miconazole Nitrate, 2%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information