Hemorrhoidal Pain Relief Cream with Aloe and Vitamin E

Manufacturer
NeilMed pharmaceuticals Inc.
Effective date
2023-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:40

Label at a glance#

ProductHemorrhoidal Pain Relief with Aloe and VitaminE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, PETROLATUM, PRAMOXINE HYDROCHLORIDE, GLYCERIN
Label structure17 sections

Indications and 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.

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 m...

Label contents#

Full prescribing information#

Drug Facts - Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 14.4%
Phenylephrine Hydrochloride 0.25%
Pramoxine Hydrochloride 1%
White petrolatum 15%

Purpose

OTC - PURPOSE SECTION


Glycerin 14.4% ..................................................................... Protectant
Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
Pramoxine Hydrochloride 1% ...................................... Local Anesthetic
White petrolatum 15% .......................................................... Protectant

Uses:

INTENDED USE OF THE DEVICE

􀁑􀀃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

​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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are 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

If pregnant or breast-feeding, 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 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.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, 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?

OTHER SAFETY INFORMATION

Questions? 1 (877) 477-8633

TAMPER EVIDENT:

USER SAFETY WARNINGS SECTION

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

Important

SAFE HANDLING WARNING SECTION

Important: 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.

Use

INDICATIONS & USAGE SECTION

swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation

Package label _Outer carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relief Cream with AloePain Relief Cream with Aloe

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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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-324-01Hemorrhoidal Pain Relief with Aloe and VitaminE1 in 1 CARTONCREAM11
13709-324-01Hemorrhoidal Pain Relief with Aloe and VitaminE51 g in 1 TUBECREAM511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-324HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE CREAM [NEILMED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20231012_076b5021-8ba0-0204-e063-6294a90a3337.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-32413709-324-01

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 Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
ndc (package): 13709-324-01
ndc (product): 13709-324
ndc11 (package): 13709032401
spl id: 076b5021-8ba1-0204-e063-6294a90a3337
spl set id: 076b5021-8ba0-0204-e063-6294a90a3337

Reported adverse events (FAERS/openFDA)#

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