FDA.reportPublic FDA data

Hemorrhoid, Fissure, ProctalgiaSuppositories

Manufacturer
WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:33:01

Label at a glance#

ProductHemorrhoid, Fissure, ProctalgiaSuppositories
Active ingredientPEPPERMINT OIL, GLYCERIN, ACTIVATED CHARCOAL, SODIUM SULFATE, BORNEOL
Label structure9 sections

Storage and handling

Additionalinformation:store in a cool, dry place.It is recommended tostore below 68°F(20°C)Refrigeration is advised.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbon 1%
Mirabilite 2%
Peppermint oil 0.2%
Borneol 3%

Glycerin 8%

OTC - PURPOSE SECTION

Adsorbent and detoxifying
Anti-inflammatory and soothing
Cooling and analgesic
Analgesic and anti-inflammatery
Humectant and moisturizing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach ofchildren.
lf swallowed, seek medicalhelp or contact a PolsonControl Center right away.

INDICATIONS & USAGE SECTION

temporarily protects the inflamed, irritatedanorectal surface to help make bowel movementsless painful from irritation and abrasion duringbowel movement
*provides temporary relief of pain, soreness, orburning*helps relieve the local or anorectal itching anddiscomfort associated with hemorrhoids

WARNINGS SECTION

For external and/or intrarectal use.

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over:when practical, cleanse area with mild soap andwarm water and rinse thoroughly.Gently dry bypatting or blotting with toilet tissue or a soft clothbefore applying.Apply to the affected area up to 4 times daily,especially at night, in the morning or after eachbowel movement.For intrarectal use: after wetting, apply around theanal area and then insert into the rectum..children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Additionalinformation:store in a cool, dry place.It is recommended tostore below 68°F(20°C)Refrigeration is advised.

INACTIVE INGREDIENT SECTION

Polyethylene Glycol
POLYSORBATE 60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PEPPERMINT Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84533-001-01Hemorrhoid, Fissure, ProctalgiaSuppositories7 g in 1 BOXSUPPOSITORY74

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84533-00184533-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERINPDC6A3C0OXACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
SODIUM SULFATE0YPR65R21JACTIB
BORNEOLM89NIB437XACTIB

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
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
ndc (package): 84533-001-01
ndc (product): 84533-001
ndc11 (package): 84533000101
spl id: 486510a7-f140-3a89-e063-6294a90a7bf7
spl set id: 1d40d16a-ee52-463a-e063-6394a90a6077

Reported adverse events (FAERS/openFDA)#

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