FDA.reportPublic FDA data

ProCure Hemorrhoidal

Manufacturer
Twin Med LLC
Effective date
2025-06-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:18

Label at a glance#

ProductProCure Hemorrhoidal
Active ingredientPETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL
Label structure8 sections

Indications and uses

Uses helps relieve the local ithcing and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue and relieves burning temporarity provides a coating for relief of anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and administration

Directions Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Genrly dry by patting or blotting with toilet tissue or a soft cloth before applying ointment. INTERARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Mineral Oil 14%......................Protectant

Petrolatum 74.9%...................Protectant

Phenylephrine HCl 0.25%......Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

Uses

  • helps relieve the local ithcing and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieves burning
  • temporarity provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

WARNINGS SECTION

Warnings

for external and / or intrarectal use only.

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

When using this product

OTC - WHEN USING SECTION

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into the rectum causes additional pain

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of Children

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 (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Genrly dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
  • INTERARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace the cover.
  • EXTERNAL USE: apply to affected area
  • Apply to affected area up to 4 times daily
  • Children under 12 yeras of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Benzoic Acid, Betylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, Lanolin Alcohols, Methylparaben, Mineral Oil, Paraffin, Propylparaben, Purifed Water, Thyme Oil, Vitamin E, White Wax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCH002 ImagePCH002 Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN2
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD2
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-021-02ProCure Hemorrhoidal56.6 g in 1 TUBE, WITH APPLICATOROINTMENT56.62

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
55681-02155681-021-02

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
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLPARABENZ8IX2SC1OHIACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UACTIB
PARAFFINI9O0E3H2ZEIACT
WHITE WAX7G1J5DA97FIACT
BENZOIC ACID8SKN0B0MIMIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
THYME OIL2UK410MY6BIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CORN OIL8470G57WFMIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPACTIB

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
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
ndc (package): 55681-021-02
ndc (product): 55681-021
ndc11 (package): 55681002102
spl id: 37cdd72a-2001-148c-e063-6394a90af289
spl set id: 37a4cc43-0d53-f1bf-e063-6394a90a2dc9

Reported adverse events (FAERS/openFDA)#

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