Hemorrhoidal Pain Relief Cream

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2025-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:02

Label at a glance#

ProductHemorrhoidal Pain Relief
Active ingredientPRAMOXINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, GLYCERIN, PETROLATUM
Label structure16 sections

Indications and uses

For temporary relief from pain 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 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, puncture foil seal with top end of cap. Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or ...

Label contents#

Full prescribing information#

Drug Facts:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

Petrolatum 15%

Drug Facts:

OTC - PURPOSE SECTION

Purpose

Protectant

Vasoconstrictor

Local Anesthetic

Protectant

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief from pain 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 in urination due to enlargement of prostate gland

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 the recommended daily dosage unless directed by a doctor.
  • Do not put in the rectum by using fingers or any mechanical device or applicator.

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
  • An allergic reaction occurs
  • The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 cream.
  • When first opening the tube, puncture foil seal with top end of cap.
  • Apply externally or in the lower portion of the anal canal only.
  • Apply 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 using cream from the tube, then gently insert dispensing cap partway into anus. Thoroughly cleanse dispensing cap after each use and replace cover.
  • Children under 12 years of age: ask a doctor.

Other information:

OTHER SAFETY INFORMATION

storage temperature: not to exceed 30°C (86°F). Protect from freezing.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe vera leaf, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate

Questions or comments?

OTC - QUESTIONS SECTION

1 (877) 477-8633

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Important:

OTHER SAFETY INFORMATION

Please do not discard this printed box and any enclosed printed material.
The inside final product may not have all the details you require for the ongoing use of the product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoidal CreamHemorrhoidal Cream

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
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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
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-335-01Hemorrhoidal Pain Relief1 in 1 CARTONCREAM12
13709-335-01Hemorrhoidal Pain Relief51 g in 1 TUBECREAM512

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
13709-33513709-335-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
ndc (package): 13709-335-01
ndc (product): 13709-335
ndc11 (package): 13709033501
spl id: 3f904257-3af2-2c97-e063-6294a90aecae
spl set id: 374dc1c0-4243-b272-e063-6394a90a5a6b

Reported adverse events (FAERS/openFDA)#

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