MIRACTIL- hemorrhoidal cream gel

MIRACTIL by

Drug Labeling and Warnings

MIRACTIL by is a Otc medication manufactured, distributed, or labeled by POLIMEROS Y SERVICIOS S.A-, POLIMEROS Y SERVICIOS S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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INGREDIENTS AND APPEARANCE

MIRACTIL 
hemorrhoidal cream gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69492-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	125 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	125 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	150 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	125 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52)
METHYLPARABEN (UNII: A2I8C7HI9T)
ORTHOSILICIC ACID (UNII: 623B93YABH)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
POLYCARBOPHIL (UNII: W25LM17A4W)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69492-011-06	1 in 1 BOX	03/04/2019
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	05/20/2015

Labeler - POLIMEROS Y SERVICIOS S.A- (815740251)

Establishment
Name	Address	ID/FEI	Business Operations
POLIMEROS Y SERVICIOS S.A.		815740251	manufacture(69492-011)