NDC 58443-0243

Australian Gold Metro 365 Medicated Leave-In Treatment Step 3

Pyrithione Zinc 0.22%

Australian Gold Metro 365 Medicated Leave-In Treatment Step 3 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Pyrithione Zinc.

• Product ID: 58443-0243_405720c0-99c2-1d6d-e054-00144ff8d46c
• NDC: 58443-0243
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Metro 365 Medicated Leave-In Treatment Step 3
• Generic Name: Pyrithione Zinc 0.22%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-10-12
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part358H
• Labeler Name: Prime Enterprises Inc.
• Substance Name: PYRITHIONE ZINC
• Active Ingredient Strength: 2 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0243-3

118 mL in 1 TUBE (58443-0243-3)

• Marketing Start Date: 2016-10-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0243-3 [58443024303]

Australian Gold Metro 365 Medicated Leave-In Treatment Step 3 CREAM

• Marketing Category: OTC monograph final
• Application Number: part358H
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-12

Drug Details

Active Ingredients

Ingredient	Strength
PYRITHIONE ZINC	2.14 mg/mL

OpenFDA Data

• SPL SET ID: 405720c0-99c1-1d6d-e054-00144ff8d46c
• Manufacturer:
  • Prime Enterprises Inc.
• UNII:
  • R953O2RHZ5