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 intrarectal use only
Ask doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty 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 (1-800-222-1222)
Directions
Adults:
- When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or with a soft cloth before applying ointment
- Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- Intrarectal Use: Remove cover from applicator, attach applicator to tube, lubricate applicator well, and gently insert applicator into rectum. thoroughly cleanse applicator after each use and replace cover.
- Also apply ointment to external area
- Regular use provides continual therapy for relief of symptoms
- Children under 12 years of age: ask a doctor
Other Information
- Store at room temperature 20°-25°C (68°-77°F)
Questions? Call 1-888-296-9067
Distributed By
CVS Pharmacy Inc.
One CVS Drive
Woonsocket, RI 02895
©2020 CVS Pharmacy
CVS.com
1-800-SHOP CVS
Made in China
V-36582
CVS Quality Money Back guarantee
This product is not manufactured or distributed by Wyeth LLC, owner of registered trademark Preparation H®
Inactive Ingredients
Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol
* Please review the disclaimer below.