FDA.reportPublic FDA data

Drs. pharmacy HEMORRHOIDAL COOLING

Manufacturer
OL PHARMA TECH, LLC Drs PHARMACY
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:52:20

Label at a glance#

ProductDrs. pharmacy HEMORRHOIDAL COOLING
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL
Label structure15 sections

Indications and uses

helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas

Dosage and administration

adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel. when first opening the tube, puncture foil seal with top end of cap apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement children under 12 years of age:...

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

  1. Phenylephrine HCI, 0.25%
  2. Witch Hazel, 50.0%

PURPOSE

OTC - PURPOSE SECTION

  • Vasoconstrictor
  • Astringent

USES

INDICATIONS & USAGE SECTION

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas

WARNINGS

WARNINGS SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently 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 this product into the rectum by using fingers or any mechanical device or applicator

STOP USING AND ASK YOUR DOCTOR IF

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days

IF PREGNENT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hemorroidal cooling gelhemorroidal cooling gel

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-959-01Drs. pharmacy HEMORRHOIDAL COOLING20 g in 1 TUBEGEL208
80489-959-01Drs. pharmacy HEMORRHOIDAL COOLING1 in 1 CARTONGEL18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-959DRS. PHARMACY HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [OL PHARMA TECH, LLC DRS PHARMACY]8Current NDC, Legacy NDC, 2 package rows20250112_d6f6b482-d85d-001c-e053-2995a90ad98c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-95980489-959-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM METABISULFITE4VON5FNS3CIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WITCH HAZEL101I4J0U34ACTIB

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
Drs. pharmacy HEMORRHOIDAL COOLINGPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACYd6f6b482-d85d-001c-e053-2995a90ad98c2025-01-09WarningsExact identifier
ndc (package): 80489-959-01
ndc (product): 80489-959
ndc11 (package): 80489095901
spl id: 2b521bcb-3d08-f590-e063-6294a90a36c0
spl set id: d6f6b482-d85d-001c-e053-2995a90ad98c

Reported adverse events (FAERS/openFDA)#

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