Active Ingredient
Phenylephrine HCI 0.25%
Mineral Oil 14%
Petrolatum 74.9%
Hemorrhoidalointment
FDA Label NDC 69396-133
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Hemorrhoidalointment (NDC 69396-133). 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, when using this product, 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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
- Introduction of applicator into the rectum causes additional pain
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
Stop Use And Ask Doctor If
- Bleeding occurs
- Condition worsens or does not improve within 7 days
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
When Using This Product
When using this product do not exceed the recommended dosage unless directed by a doctor
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 and attach to tube
- Lubricate applicator well, then gently insert applicator into rectum
- Thoroughly clean applicator and replace protective cover after each use
- Clean the affected area and pat or dab dry before applying ointment
- 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, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol
Questions
Call 1-800-883-0085
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