Active Ingredient
Phenylephrine HCI 0.25%
Mineral Oil 14%
Petrolatum 74.9%
Hemorrhoidalointment
FDA Label NDC 69396-020
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 69396-020). 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 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.
