Hemorrhoidal Pain Relief
Hemorrhoidal Pain Relief Ointment
374d89b6-9305-9adf-e063-6394a90adb32
HUMAN OTC DRUG LABEL
Jun 11, 2025
Neilmed Pharmaceuticals Inc.
DUNS: 799295915
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hemorrhoidal Pain Relief Ointment
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses:
- Helps relieve the local itching and discomfort associated with hemorrhoids
- Temporarily shrinks hemorrhoidal tissue and relieves burning
- Temporarily provides a coating for relief of anorectal discomforts
- Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active Ingredients:
Mineral Oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
OTC - PURPOSE SECTION
Drug Facts:
Purpose
Protectant
Protectant
Vasoconstrictor
WARNINGS SECTION
Warnings:
For external and/or intrarectal 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 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
OTC - STOP USE SECTION
Stop use and ask doctor if:
- Bleeding occurs
- Condition worsens or does not improve within 7 days
- Introduction of applicator into the rectum causes additional pain
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 ointment.
- When first opening the tube, puncture foil seal with top end of cap.
- Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- Intrarectal use: Remove cover from the applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover.
- Also apply ointment to external area.
- Regular use provides continual therapy for relief of symptoms.
OTHER SAFETY INFORMATION
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.
INACTIVE INGREDIENT SECTION
Inactive ingredients:
Benzoic acid, butylated hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol, acetate, white wax
OTC - QUESTIONS SECTION
Questions or comments?
1 (877) 477-8633
TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING