MIRACTIL- hemorrhoidal cream gel 
POLIMEROS Y SERVICIOS S.A-

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Submission for Miractil Hemorrhoidal Cream

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MIRACTIL 
hemorrhoidal cream gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69492-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER125 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN125 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION125 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69492-011-061 in 1 BOX03/04/2019
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/20/2015
Labeler - POLIMEROS Y SERVICIOS S.A- (815740251)
Establishment
NameAddressID/FEIBusiness Operations
POLIMEROS Y SERVICIOS S.A.815740251manufacture(69492-011)

Revised: 3/2019
Document Id: 859e65fa-f696-4e4c-bec2-cecb40038b2a
Set id: 4b6a4e76-1c37-4163-8a8d-b8a4f926b15b
Version: 4
Effective Time: 20190305
 
POLIMEROS Y SERVICIOS S.A-