Active Ingredients
Mineral Oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
Procure Hemorrhoidal Ointment
FDA Label NDC 55681-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Procure Hemorrhoidal (NDC 55681-021). 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 active ingredients, purpose, uses, warnings, ask doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Mineral Oil 14%......................Protectant
Petrolatum 74.9%...................Protectant
Phenylephrine HCl 0.25%......Vasoconstrictor
Uses
Uses
- helps relieve the local ithcing and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue and relieves burning
- temporarity 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 Doctor Before Use If You Have
Ask doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You
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
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Stop Use And Ask A Doctor If
Stop use and ask a 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
Directions
- Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Genrly dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
- INTERARECTAL 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 the cover.
- EXTERNAL USE: apply to affected area
- Apply to affected area up to 4 times daily
- Children under 12 yeras of age: consult a doctor.
Inactive Ingredients
Inactive ingredients: Benzoic Acid, Betylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, Lanolin Alcohols, Methylparaben, Mineral Oil, Paraffin, Propylparaben, Purifed Water, Thyme Oil, Vitamin E, White Wax
* Please review the disclaimer below.
