Active Ingredients
Mineral oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
Avedana Hemorrhoidal Pain Relief
FDA Label NDC 43749-480
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Hemorrhoidal Pain Relief (NDC 43749-480). 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 ingredients, purposes, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Protectant
Protectant
Vasoconstrictor
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 protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings
For external and/or intrarectal use only
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking a prescription drug for high blood pressure or depression.
When Using This Product
do not exceed the recommended daily dosage unless directed by a doctor.
Stop Use And Ask A 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 health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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 a soft cloth before applying ointment.
- when first opening the tube, puncture foil seal with top end of cap
- 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 the 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 15°C - 30°C (59°F -86°F)
Inactive Ingredients
benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax
Questions Or Comments?
Call weekdays 9 AM to 5 PM EST at 1-724-733-7381
Principal Display Panel - 57 G Tube Label
THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.
Avedana®
HEMORRHOIDAL PAIN RELIEF OINTMENT
Prevents Further
Irritation
- Prompt, Soothing Relief from Painful
Burning, Itching and Discomfort - Shrinks Swollen Hemorrhoidal Tissue
- Protects Irritated Tissue
- Relieves Internal and External Discomfort
NET WT 2 OZ (57 g)
Principal Display Panel (57 g Tube Label)
Principal Display Panel - 57 G Carton Label
Avedana®
HEMORRHOIDAL PAIN RELIEF OINTMENT
Prevents Further Irritation
•Prompt, Soothing Relief from Painful
Burning, Itching, & Discomfort
•Shrinks Swollen Hemorrhoidal Tissue
•Protects Irritated Tissue
•Relieves Internal & External Discomfort
1 TUBE | NET WT 2 OZ (57 g)
Principle Display Panel (57 g Carton Label)
* Please review the disclaimer below.
