Submission for Miractil Hemorrhoidal Cream

Manufacturer: POLIMEROS Y SERVICIOS S.A- | POLIMEROS Y SERVICIOS S.A.
Effective date: 2019-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:58:42

Label at a glance#

ProductMIRACTIL

Active ingredientCOCOA BUTTER, GLYCERIN, MENTHOL, PETROLATUM, ZINC OXIDE

Label structure11 sections

Dosage and administration

Directions.jpg Information shown both on container label and package

Label contents#

Full prescribing information#

Detail showing Active Ingredient from package

OTC - ACTIVE INGREDIENT SECTION

Active ingredients.jpg

Information shown both on container label and paclage

image description

Detail showing Inactive ingredient from package

INACTIVE INGREDIENT SECTION

Inactive ingredinets.jpg

Information shown both on cntainer label and package

image description

Detail showing Purpose within Active Ingredients from package

OTC - PURPOSE SECTION

Purpose.jpg

Information shown both on container label and package

image description

Detail showing Indications from pacage

INDICATIONS & USAGE SECTION

Indications.jpg

Information shown both on container label and package

image description

Detail shyowing Instructions for use and named Directions from package

INSTRUCTIONS FOR USE SECTION

Directions.jpg

Information shown both on container label and package

image description

Detail showing Dosage abd Administration within Directions from package

DOSAGE & ADMINISTRATION SECTION

Dosage and administration.jpg

Information shown both on container lable and package

image description

Detail showing Warnings from package

WARNINGS SECTION

Warnings.jpg

Information shown both on container label and package

image description

Detail showing Keep Out of Reach of Children within Warnings from package

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reavh of children.jpg

nformation shown on package

image description

Detail showing Questions from package

OTC - QUESTIONS SECTION

Questions or comments.jpg

nformation shown both on container label and package

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Detail showing Other Safety Information from package

OTHER SAFETY INFORMATION

Other information.jpg

Information shown both on container label and package

image description

Representative sample image of carton/container label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container label.jpg

General view of inner container label

image description

Package content of labeling.jpg

General view of box content of labeling

image description

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GLYCERIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69492-011-06	2022-01-28	C162847	48780-1	d6a99b39-3599-a426-e053-dadaa90af4c2	Submission for Miractil Hemorrhoidal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69492-011-06	MIRACTIL	30 g in 1 TUBE	GEL	30		4
69492-011-06	MIRACTIL	1 in 1 BOX	GEL	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69492-011	MIRACTIL (HEMORRHOIDAL CREAM) GEL [POLIMEROS Y SERVICIOS S.A-]	4	Legacy NDC, 2 package rows	20190306_4b6a4e76-1c37-4163-8a8d-b8a4f926b15b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	2
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	2
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	2
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	2
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	2
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	2
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)	INACTIVE INGREDIENT	5GV09YMO52	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	2
ORTHOSILICIC ACID	INACTIVE INGREDIENT	623B93YABH	2
POLYCARBOPHIL	INACTIVE INGREDIENT	W25LM17A4W	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

MIRACTIL
Hemorrhoidal Cream
COCOA BUTTER
GLYCERIN
MENTHOL
PETROLATUM
ZINC OXIDE
ZINC CATION
CARBOXYPOLYMETHYLENE
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)
METHYLPARABEN
ORTHOSILICIC ACID
SODIUM PHOSPHATE, DIBASIC
POLYCARBOPHIL
PROPYLPARABEN
WATER
MINERAL OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69492-011	69492-011-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COCOA BUTTER	512OYT1CRR	ACTIB
GLYCERIN	PDC6A3C0OX	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIM
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)	5GV09YMO52	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ORTHOSILICIC ACID	623B93YABH	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
POLYCARBOPHIL	W25LM17A4W	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 208 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYCARBOPHIL	POLYCARBOPHIL	W25LM17A4W	SUSPENSION/ DROPS / OPHTHALMIC	0.86 %w/v		Exact identifier — unii candidate 8 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POLYCARBOPHIL	POLYCARBOPHIL	W25LM17A4W	GEL / VAGINAL		100 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TRANSDERMAL		150 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / SUBCUTANEOUS		14 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYCARBOPHIL	POLYCARBOPHIL	W25LM17A4W	GEL / OPHTHALMIC		1 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	CREAM / TOPICAL		103 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
859e65fa-f696-4e4c-bec2-cecb40038b2a			4b6a4e76-1c37-4163-8a8d-b8a4f926b15b	2019-03-05	Warnings	Exact identifier spl id: 859e65fa-f696-4e4c-bec2-cecb40038b2a spl set id: 4b6a4e76-1c37-4163-8a8d-b8a4f926b15b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.