NeilMed Hemorrhoidal Pain Relief Ointment with Aloe and Vitamin E 51g

Manufacturer
NeilMed Pharmaceuticals Inc.
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:26:52

Label at a glance#

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

Storage and handling

store at 15°C - 30°C (59°F - 86°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Drug Facts

OTC - PURPOSE SECTION

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

Drug Facts : Uses

INDICATIONS & USAGE SECTION

􀁑􀀃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.

Drug Facts

WARNINGS SECTION

Warnings: 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

Ask a doctor or pharmacist before use 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.

Other information:

STORAGE AND HANDLING SECTION

store at 15°C - 30°C (59°F - 86°F)

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

TAMPER EVIDENT:

SAFE HANDLING WARNING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoidal pain relief aloe and vit EHemorrhoidal pain relief aloe and vit E

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-32013709-320-01

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
079306dd-1f08-ae05-e063-6394a90a477a03ad5448-1bfc-5163-e063-6394a90ab5cf2023-10-13WarningsExact identifier
spl set id: 03ad5448-1bfc-5163-e063-6394a90ab5cf

Reported adverse events (FAERS/openFDA)#

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