VUSION- miconazole nitrate, zinc oxide, white petrolatum ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Miconazole nitrate, zinc oxide and white petrolatum ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment. Miconazole nitrate, zinc oxide and white petrolatum ointment should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as a substitute for frequent diaper changes. The safety and efficacy of miconazole nitrate, zinc oxide and white petrolatum

Product summary:

Miconazole Nitrate, 0.25%, Zinc Oxide, 15% and White Petrolatum, 81.35% Ointment contains 2.5 mg of miconazole nitrate, USP, 150 mg of zinc oxide, USP and 813.5 mg of white petrolatum, USP per gram. The smooth, uniform, white ointment supplied in an aluminum tube is available as follows: NDC 0378-8222-50 carton containing one 50 gram tube Store at 20 ° to 25 °C (68 ° to 77 °F). [See USP Controlled Room Temperature.] Keep out of reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

VUSION- MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM OINTMENT
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MICONAZOLE NITRATE, ZINC OXIDE AND
WHITE PETROLATUM OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MICONAZOLE
NITRATE, ZINC OXIDE AND WHITE PETROLATUM OINTMENT.
MICONAZOLE NITRATE, ZINC OXIDE AND WHITE PETROLATUM OINTMENT, FOR
TOPICAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Indication
1.2 Limitations of Use
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
Miconazole nitrate, zinc oxide and white petrolatum ointment is
indicated for adjunctive treatment of diaper dermatitis
when complicated by documented candidiasis (microscopic evidence of
pseudohyphae and/or budding yeast) in
immunocompetent pediatric patients 4 weeks and older. (1.1)
Miconazole nitrate, zinc oxide and white petrolatum ointment should
not be used as a substitute for frequent diaper
changes. (1.1)
Miconazole nitrate, zinc oxide and white petrolatum ointment should
not be used to prevent the occurrence of diaper
dermatitis, since preventative use may result in the development of
drug resistance. (1.2)
Miconazole nitrate, zinc oxide and white petrolatum ointment is for
topical use only. Miconazole nitrate, zinc oxide and
white petrolatum ointment is not for oral, ophthalmic, or intravaginal
use. (2)
Miconazole nitrate, zinc oxide and white petrolatum ointment should be
applied as a thin layer to the affected area at
each diaper change for 7 days. (2)
Miconazo