FDA.reportPublic FDA data

Rexall ® Hemorrhoidal Cream Topical

Manufacturer
Dolegencorp,LLC | Natureplex LLC
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:50

Label at a glance#

ProductRexall Hemorrhoidal
Active ingredientGlycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Petrolatum
Label structure8 sections

Indications and uses

temporarily relieves pain, soreness, and burning helps relieve local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue temporarily 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

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 cream. when first opening tube, remove foil seal apply externally or in lower portion of anal canal only apply externally to affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement for applicati...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Glycerin 14.4%Protectant
Petrolatum 15%Protectant
Phenylephrine hydrochloride 0.25%Vasoconstrictor
Pramoxine hydrochloride 1%Local anesthetic

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves pain, soreness, and burning
  • helps relieve local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily 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

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 urinating due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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
  • the 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: 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 cream.
  • when first opening tube, remove foil seal
  • apply externally or in lower portion of anal canal only
  • apply externally to affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
  • for application in lower anal canal; remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into anus
  • thoroughly cleanse dispensing cap after each use, and replace cover
  • Children under 12 years: 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 PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, mineral oil, panthenol, phenoxy ethenol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55910-331-24

Since 1903
Rexall®

MAXIMUM STRENGTH

Hemorrhoidal Cream

  • Rapid, soothing pain relief from burning, itching and discomfort
  • Protects irritated tissue

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-331-24Rexall Hemorrhoidal1 in 1 CARTONCREAM15
55910-331-24Rexall Hemorrhoidal28 g in 1 TUBECREAM285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-331REXALL HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, AND PETROLATUM) CREAM [DOLEGENCORP,LLC]5Legacy NDC, 2 package rows20241222_bf4b6237-90c3-415f-a5dd-e0f777bde60a.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-33155910-331-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
GlycerinPDC6A3C0OXACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
Pramoxine Hydrochloride88AYB867L5ACTIB
Petrolatum4T6H12BN9UACTIB
Aloe Vera LeafZY81Z83H0XIACT
Butylated HydroxyanisoleREK4960K2UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
Cetostearyl Alcohol2DMT128M1SIACT
Citric Acid Monohydrate2968PHW8QPIACT
Edetate Disodium7FLD91C86KIACT
Glyceryl Monostearate230OU9XXE4IACT
Laureth-23N72LMW566GIACT
Mineral OilT5L8T28FGPIACT
PanthenolWV9CM0O67ZIACT
Propyl Gallate8D4SNN7V92IACT
Propylene Glycol6DC9Q167V3IACT
Sodium BenzoateOJ245FE5EUIACT
Steareth-2V56DFE46J5IACT
Steareth-20L0Q8IK9E08IACT
Stearyl Alcohol2KR89I4H1YIACT
TocopherolR0ZB2556P8IACT
.Alpha.-TocopherolH4N855PNZ1IACT
Water059QF0KO0RIACT
Xanthan GumTTV12P4NEEIACT

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
e8b9f660-3768-4138-962b-16ad8a1e3e89bf4b6237-90c3-415f-a5dd-e0f777bde60a2024-12-17WarningsExact identifier
spl id: e8b9f660-3768-4138-962b-16ad8a1e3e89
spl set id: bf4b6237-90c3-415f-a5dd-e0f777bde60a

Reported adverse events (FAERS/openFDA)#

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