FDA.reportPublic FDA data

Hemorrhoidal cooling gel

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2023-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:12

Label at a glance#

ProductHemorrhoidal cooling gel
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL
Label structure9 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, peel off the foil seal 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 HCl 0.25%
Witch hazel 50.0%

Purposes

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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 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 unless directed by a doctor
  • 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 worsens or does not improve within 7 days

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 (1-800-222-1222).

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, peel off the foil seal
  • 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

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, edetate disodium,hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol,propylparaben,purified water, sodium citrate, sulisobenzone, vitamin E acetate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

735A-Walgreens-Hemorrhoidal cooling gel-carton.jpg735A-Walgreens-Hemorrhoidal cooling gel-carton.jpg735A-Walgreens-Hemorrhoidal cooling gel-tube.jpg735A-Walgreens-Hemorrhoidal cooling gel-tube.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN2
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD2
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY2

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9712-01Hemorrhoidal cooling gel1 in 1 CARTONGEL12
0363-9712-01Hemorrhoidal cooling gel26 g in 1 TUBEGEL262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9712HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WALGREENS]2Current NDC, 2 package rows20240115_03bbe258-e00d-13cc-e063-6394a90ae345.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-97120363-9712-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CITRATE1Q73Q2JULRIACT
SULISOBENZONE1W6L629B4KIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WITCH HAZEL101I4J0U34ACTIB
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT

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
Hemorrhoidal cooling gelPHENYLEPHRINE HCL, WITCH HAZELWALGREENS03bbe258-e00d-13cc-e063-6394a90ae3452023-12-05WarningsExact identifier
ndc (package): 0363-9712-01
ndc (product): 0363-9712
ndc11 (package): 00363971201
spl id: 0bbdecbd-91ce-600d-e063-6294a90a4ca4
spl set id: 03bbe258-e00d-13cc-e063-6394a90ae345