FDA.reportPublic FDA data

REXALL HEMORRHOIDAL COOLING GEL

Manufacturer
Dolgencorp, Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2017-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:55

Label at a glance#

ProductREXALL HEMORRHOIDAL COOLING
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL
Label structure8 sections

Indications and uses

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

Dosage and administration

Adults : when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or 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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine Hydrochloride  0.25%
Witch Hazel   50%

Purpose

OTC - PURPOSE SECTION

Vasoconstrictor
Astringent

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

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.

OTC - WHEN USING SECTION

When using this product

  • do not exceed the recommended daily dosage
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not improve within 7 days

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or 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

SPL UNCLASSIFIED SECTION

  • store at 20°-25°C (68°-77°F)
  • for lot number and expiration date, see crimp of tube or see box

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)

Principal display panel - 26 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REXALL HEMORRHOIDAL COOLING GEL

NET WT .9 OZ (26 g)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN1
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD1
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY1

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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-416-262020-01-31C16284748780-19d75b9d1-0f66-f424-e053-dadaa90a57ceREXALL HEMORRHOIDAL COOLING GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-416-26REXALL HEMORRHOIDAL COOLING26 g in 1 TUBEGEL261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-416REXALL HEMORRHOIDAL COOLING (PHENYLEPHRINE HYDROCHLORIDE AND WITCH HAZEL) GEL [DOLGENCORP, INC.]1Legacy NDC, 1 package rows20170713_8dd3206b-7b17-41ee-a66f-98f9d3d1ae8f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-41655910-416-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
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
54358a22-13fd-2b91-e054-00144ff88e888dd3206b-7b17-41ee-a66f-98f9d3d1ae8f2017-07-13WarningsExact identifier
spl id: 54358a22-13fd-2b91-e054-00144ff88e88
spl set id: 8dd3206b-7b17-41ee-a66f-98f9d3d1ae8f

Reported adverse events (FAERS/openFDA)#

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