NDC 69492-011

MIRACTIL

Hemorrhoidal Cream

MIRACTIL is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Polimeros Y Servicios S.a-. The primary component is Cocoa Butter; Glycerin; Menthol; Petrolatum; Zinc Oxide.

• Product ID: 69492-011_859e65fa-f696-4e4c-bec2-cecb40038b2a
• NDC: 69492-011
• Product Type: Human Otc Drug
• Proprietary Name: MIRACTIL
• Generic Name: Hemorrhoidal Cream
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-05-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: POLIMEROS Y SERVICIOS S.A-
• Substance Name: COCOA BUTTER; GLYCERIN; MENTHOL; PETROLATUM; ZINC OXIDE
• Active Ingredient Strength: 125 mg/g; mg/g; mg/g; mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69492-011-06

1 TUBE in 1 BOX (69492-011-06) > 30 g in 1 TUBE

• Marketing Start Date: 2019-03-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69492-011-06 [69492001106]

MIRACTIL GEL

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-03-04

Drug Details

Active Ingredients

Ingredient	Strength
COCOA BUTTER	125 mg/g

OpenFDA Data

• SPL SET ID: 4b6a4e76-1c37-4163-8a8d-b8a4f926b15b
• Manufacturer:
  • POLIMEROS Y SERVICIOS S.A-
• UNII:
  • SOI2LOH54Z
  • L7T10EIP3A
  • PDC6A3C0OX
  • 512OYT1CRR
  • 4T6H12BN9U

NDC Crossover Matching brand name "MIRACTIL" or generic name "Hemorrhoidal Cream"

NDC	Brand Name	Generic Name
69492-011	MIRACTIL	Hemorrhoidal Cream
0363-0641	Hemorrhoidal Cream	Hemorrhoidal Cream
43749-470	Hemorrhoidal Cream	Hemorrhoidal Cream