FDA.reportPublic FDA data

Hemorrhoidal Pain Relief Cream

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:12

Label at a glance#

ProductHemorrhoidal Pain Relief Cream
Active ingredientGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Glycerin 14.4%
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
White petrolatum 15%

OTC - PURPOSE SECTION

Purposes
Protectant
Vasoconstrictor
Local anesthetic
Protectant

INDICATIONS & USAGE SECTION

Uses
• for temporary relief of pain, soreness and burning
• helps relieve the 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

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

WARNINGS 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 into 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
  • 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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 cream.
  • when first opening the tube, peel off the foil seal
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

  • store at 20-25 °C (68-77 °F)

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe barbadensis leaf extract, butylated hydroxy anisole, cetostearyl alcohol, cetyl ester wax, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, vitamin E acetate

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

737A-WG-Hemo-tube-51g737A-WG-Hemo-tube-51g737A-WG-Hemo-ifc-51g737A-WG-Hemo-ifc-51g737A-WG-Hemo-ifc-25g737A-WG-Hemo-ifc-25g737A-WG-Hemo-Tube-25g737A-WG-Hemo-Tube-25g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN2
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD2
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY2

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
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
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
0363-9127-01Hemorrhoidal Pain Relief Cream25.5 g in 1 TUBECREAM25.52
0363-9127-01Hemorrhoidal Pain Relief Cream1 in 1 CARTONCREAM12
0363-9127-03Hemorrhoidal Pain Relief Cream51 g in 1 TUBECREAM512
0363-9127-03Hemorrhoidal Pain Relief Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9127HEMORRHOIDAL PAIN RELIEF CREAM (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WALGREENS]2Current NDC, 4 package rows20240115_03bbe146-f185-bcfa-e063-6394a90a85bf.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-91270363-9127-01, 0363-9127-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
PETROLATUM4T6H12BN9UACTIB
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ESTERS WAXD072FFP9GUIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYL PALMITATE5ZA2S6B08XIACT
POLYSORBATE 60CAL22UVI4MIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CITRATE1Q73Q2JULRIACT

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 Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
ndc (package): 0363-9127-03
ndc (package): 0363-9127-01
ndc (product): 0363-9127
ndc11 (package): 00363912701
ndc11 (package): 00363912703
spl id: 0b813c5b-d221-6a4e-e063-6394a90aa8a1
spl set id: 03bbe146-f185-bcfa-e063-6394a90a85bf

Reported adverse events (FAERS/openFDA)#

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