FDA.reportPublic FDA data

PROCURE Hemorrhoidal Cream

Manufacturer
TWIN MED, LLC
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-06 06:10:08

Label at a glance#

ProductHEMORRHOIDALCREAMPROCURE
Active ingredientMINERAL OIL, PHENYLEPHRINE HYDROCHLORIDE, PETROLATUM
Label structure8 sections

Storage and handling

Other information store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Mineral Oil (14% w/w)............................................. Skin Protectant

Petrolatum (74.9% w/w)........................................... Skin Protectant


Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor

INDICATIONS & USAGE SECTION

Uses

  • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
  • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

WARNINGS SECTION

Warnings

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,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

Directions

  • Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
  • To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
  • Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
  • Children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, PEG-40 Hydrogenated Castor Oil, PEG-100 Stearate, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130816516015878GTIN-13: 0816516015878
EAN-13: 0816516015878
GTIN-12: 816516015878
UPC-A: 816516015878
GTIN storage (14 digits): 00816516015878		Hemorrhoidal 2oz Tube procure.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-41055681-410-55

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
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PETROLATUM4T6H12BN9UACTIB
POLYOXYL 100 STEARATEYD01N1999RIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WHITE WAX7G1J5DA97FIACT
THYMUS VULGARIS LEAFGRX3499643IACT
BENZOIC ACID8SKN0B0MIMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CORN OIL8470G57WFMIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-01-08full-release2026-06-01 00:06:51

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
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
ndc (package): 55681-410-55
ndc (product): 55681-410
ndc11 (package): 55681041055
spl id: 5828171b-09e8-f8ba-e063-6294a90aeaf3
spl set id: e9c44756-1c98-41be-e053-2995a90a35b4

Reported adverse events (FAERS/openFDA)#

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