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
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
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
Adults and children 12 years of age and older for topical use:
- Clean the affected area and pat or dab dry before applying ointment
- Apply to the affected area up to 4 times daily, especially after bowel movement
- Attach included applicator to tube
- Lubricate applicator tip and gently insert into rectum
- Thoroughly clean applicator after each use and replace cover
Children under 12 years of age: ask a doctor before use
Other Information
- Store at room temperature 20°-25°C (68°-77°F)
- Close cap tightly after use
Questions? Call 1-888-296-9067
Inactive Ingredients
Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol
Distributed By:
Trifecta Pharamceuticals USA, LLC.
101 NE Third Ave. Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
* Please review the disclaimer below.