NDC 71831-003

Pranicura II

Glycerin, Kaolin, Calamine, Menthol

Pranicura II is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Pranicura Group Llc. The primary component is Glycerin; Kaolin; Zinc Oxide; Menthol.

• Product ID: 71831-003_00d0e16d-198f-48f7-a873-d1c3c58aa7a5
• NDC: 71831-003
• Product Type: Human Otc Drug
• Proprietary Name: Pranicura II
• Generic Name: Glycerin, Kaolin, Calamine, Menthol
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-01-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: PRANICURA GROUP LLC
• Substance Name: GLYCERIN; KAOLIN; ZINC OXIDE; MENTHOL
• Active Ingredient Strength: 25 g/100g; g/100g; g/100g; g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 71831-003-01

60 g in 1 JAR (71831-003-01)

• Marketing Start Date: 2020-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71831-003-01 [71831000301]

Pranicura II OINTMENT

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-15

Drug Details

Active Ingredients

Ingredient	Strength
GLYCERIN	25 g/100g

OpenFDA Data

• SPL SET ID: 8e26ca05-f30d-46f1-abf1-92a4c925413b
• Manufacturer:
  • Pranicura, LLC
• UNII:
  • SOI2LOH54Z
  • L7T10EIP3A
  • PDC6A3C0OX
  • 24H4NWX5CO

NDC Crossover Matching brand name "Pranicura II" or generic name "Glycerin, Kaolin, Calamine, Menthol"

NDC	Brand Name	Generic Name
71831-003	Pranicura II	GLYCERIN, KAOLIN, CALAMINE, MENTHOL
71831-002	Pranicura	GLYCERIN, KAOLIN, CALAMINE, MENTHOL
71831-004	Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL