Drug Facts
Active Ingredients
Mineral oil 14%
Petrolatum 74.9%
Phenylephrine Hydrochloride 0.25%
Hemorrhoidal Ointment
FDA Label NDC 13709-319
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Hemorrhoidal (NDC 13709-319). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, warnings:, ask a doctor before use if you have:, ask a doctor or pharmacist before use, when using this product:, stop use and ask doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active Ingredients Purpose
Mineral oil 14% ..................................................................... Protectant
Petrolatum 74.9%................................................................. Protectant
Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
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.
Warnings:
Warnings: For external and/or intrarectal use only
Ask A Doctor Before Use If You Have:
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.
Ask A Doctor Or Pharmacist Before Use
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:
��������Do not exceed the recommended daily dosage unless directed by a doctor.
Stop Use And Ask Doctor If:
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.
If Pregnant Or Breast-Feeding,
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control
Center right away (1-800-222-1222).
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 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.
��������Children under 12 years of age: ask a doctor.
Other Information:
Store at 15°C - 30°C (59°F - 86°F).
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
Tamper Evident Do Not Use If Seal On Tube Is Punctured Or Missing
TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
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.
* Please review the disclaimer below.
