FDA Label for Hemorrhoidalointment
View Indications, Usage & Precautions
Hemorrhoidalointment Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Phenylephrine HCI 0.25%
Mineral Oil 14%
Petrolatum 74.9%
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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Preparation H is a registered trademark of Glaxosmithkline consumer healthcare holdings US
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