Rexall Hemorrhoidal Cooling Gel

Manufacturer
DOLGENCORP, LLC | Natureplex LLC
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:53

Label at a glance#

ProductRexall Hemorrhoidal Cooling Gel
Active ingredientWitch Hazel, Phenylephrine Hydrochloride
Label structure8 sections

Indications and uses

temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas temporary relief of burning

Dosage and administration

Adults when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel apply externally to affected area up to 4 times daily or after each bowel movement Children under 12 years old: Ask a doctor.

Storage and handling

Store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Hamamelis virginiana (witch hazel) 50%Astringent
Phenylephrine hydrochloride 0.25%Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
  • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas
  • temporary relief of burning

Warnings

WARNINGS SECTION

For external use only.

Do not use this product

OTC - DO NOT USE SECTION

  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults
    • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
    • apply externally to affected area up to 4 times daily or after each bowel movement
  • Children under 12 years old: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, phenoxy ethenol, propylene glycol, purified water, sodium benzoate, sodium citrate

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55910-332-24

Since 1903
Rexall®

CLEAR, NON-GREASY FORMULA

Hemorrhoidal Cooling Gel

Enriched
with
Aloe

  • Prompt cooling relief from painful burning & itching
  • Relieves external discomfort

NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

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
55910-332-24Rexall Hemorrhoidal Cooling Gel1 in 1 CARTONCREAM14
55910-332-24Rexall Hemorrhoidal Cooling Gel26 g in 1 TUBECREAM264

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-332REXALL HEMORRHOIDAL COOLING GEL (WITCH HAZEL AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [DOLGENCORP, LLC]4Legacy NDC, 2 package rows20241222_cf6414f3-c1ef-49cf-8ebe-09192db6dd07.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
55910-33255910-332-24

Ingredients#

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

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

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
25cf5aeb-0989-4196-a7bb-651eb21f8e7ecf6414f3-c1ef-49cf-8ebe-09192db6dd072024-12-17WarningsExact identifier
spl id: 25cf5aeb-0989-4196-a7bb-651eb21f8e7e
spl set id: cf6414f3-c1ef-49cf-8ebe-09192db6dd07

Reported adverse events (FAERS/openFDA)#

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