FDA.reportPublic FDA data

Pranicura 5

Manufacturer
Sarati International, Inc.
Effective date
2024-01-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:58

Label at a glance#

ProductPranicura 5
Active ingredientGLYCERIN, KAOLIN, ZINC OXIDE, MENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Glycerin      25%
Kaolin        12.5%
Calamine   12.5%
Menthol        1%

OTC - PURPOSE SECTION

Purposes

Glycerin ....................................................Protectant
Kaolin .........................................Protectant/Anti-Itch
Calamine ....................................Protectant/Anti-Itch
Menthol .....................................................Analgesic

INDICATIONS & USAGE SECTION

Uses• Helps relieve the itching and discomfort associated with anorectal disorders •
Provides temporary relief from the symptoms of perianal skin irritation • For the temporary
relief of itching associated with moist anorectal conditions • For the temporary relief of
irritation and burning

WARNINGS SECTION

Warnings
For rectal use only
Do not useunless a prior doctor’s diagnosis of anorectal condition has been made
When using this productdo not exceed the recommended daily dosage unless
directed by a doctor
Stop use and ask a doctor if• bleeding occurs • condition worsens or does not
improve within 7 days • allergic reaction develops • symptoms being treated do not
subside or if redness, irritation, swelling, pain, other symptoms develop or increase
• Do not put this product into the rectum by using fingers or any mechanical device or
applicator.

• Remove petrolatum or greasy ointment before using this product because they
interfere with the ability of this product to adhere properly to the skin area
If pregnant or breastfeeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison
Control Center right away

DOSAGE & ADMINISTRATION SECTION

Other Informationstore at 15-30º C (59-86º F)

OTHER SAFETY INFORMATION

Other Informationstore at 15-30º C (59-86º F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,
Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium
Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol,
Silica, Stearyl Alcohol

OTC - QUESTIONS SECTION

Questions or Comments?Call weekdays 9 AM to 5 PM CST at 763-537-3419

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRANICURA 5

​Ultimate Relief from Pruritus Ani, Fissures and Hemmorhoids

Available only at: www.pranicura.com

Net Wt. 2.1 oz. (60 g)

Pranicura 5Pranicura 5

image descriptionimage description

RES

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67676-007-01Pranicura 560 g in 1 JARCREAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67676-007PRANICURA 5 (GLYCERIN, KAOLIN, CALAMINE, MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]4Current NDC, 1 package rows20240127_0fe10710-ac59-4fc5-e063-6294a90a48fc.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67676-00767676-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERINPDC6A3C0OXACTIB
KAOLIN24H4NWX5COACTIB
ZINC OXIDESOI2LOH54ZACTIM
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
ndc (package): 67676-007-01
ndc (product): 67676-007
ndc11 (package): 67676000701
spl id: 0fdf8d98-4b30-5102-e063-6394a90ae437
spl set id: 0fe10710-ac59-4fc5-e063-6294a90a48fc

Reported adverse events (FAERS/openFDA)#

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