Active Ingredient
Phenylephrine HCI 0.25%
Mineral Oil 14%
Petrolatum 74.9%
Hemorrhoidalointment
FDA Label NDC 68016-528
12 label sections · Submitted to the FDA by Pharmacy Value Alliance, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Hemorrhoidalointment (NDC 68016-528). 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 ingredient, purpose, uses, warnings, stop use and ask doctor if, if pregnant or breast-feeding, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Vasoconstrictor
Protectant
Protectant
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
For External and/or anorectal use only
Ask doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Ask doctor 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
- 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
Ask a doctor before use
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
Directions
Children under 12 years of age: ask a doctor before use
Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe
- gently dry by patting or blotting with a tissue or soft cloth before applying
- when first opening tube, remove foil seal
- for intrarectal use: remove protective cover from applicator into the rectum
- lubricate applicator well, then gently insert applicator into the rectum
- thoroughly clean applicator and replace protective cover after each use
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- also apply ointment to external area
Other Information
Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Beeswax, benzolc acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, stearyl alcohol
Distributed By:
Pharmacy Value Alliance, LLC.
407 East Lancaster Avenue
Wayne, PA. 19087
www.emersongroup.com
Product of PRC
Hemorrhoidal Ointment
- Prevents Further Irritation
- Prompt Soothing Relief from Painful Burning, Itching and Discomfort
- Shrinks Swollen Hemorrhoidal Tissue
- Protects Irritated Tissue
- Relieves Internal and External Discomfort
* Please review the disclaimer below.
