Active Ingredient
Phenylephrine HCI 0.25%
Mineral Oil 14%
Petrolatum 74.9%
Hemorrhoidal Ointment
FDA Label NDC 0536-1288
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby for the product Hemorrhoidal (NDC 0536-1288). 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 intrarectal 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.
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 doctor before use
- Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe.
- When first opening tube, remove foil seal
- Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use.
- Regular use provides continual therapy for relief of symptoms
- also apply ointment to external area.
Gently dry by patting or blotting with a tissue or soft cloth before applying.
Other Information
- Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol
Distributed By:
Distributed by RUGBY® LABORATORIES
17177 N. Laurel Park Drive, Suite 233
Livonia, MI. 48152
www.rugbylaboratories.com
Made in China
This Product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Hemorrhoidal Ointment.
Questions Or Comments?
1-800-645-2158
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