Label: MIRACTIL- hemorrhoidal cream gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69492-011-06 - Packager: POLIMEROS Y SERVICIOS S.A-
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 5, 2019
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- Detail showing Active Ingredient from package
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- Detail showing Indications from pacage
- Detail shyowing Instructions for use and named Directions from package
- Detail showing Dosage abd Administration within Directions from package
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INGREDIENTS AND APPEARANCE
MIRACTIL
hemorrhoidal cream gelProduct 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)