Drug Facts : Active Ingredients (In Each Suppository) :
Cocoa butter 88.44%
Phenylephrine Hydrochloride 0.25%
Hemorrhoidal Cocoa Butter Suppository
FDA Label NDC 13709-323
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Hemorrhoidal Cocoa Butter (NDC 13709-323). 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 drug facts : active ingredients (in each suppository) :, purpose, uses:, warnings:, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product:, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Protectant
Vasoconstrictor
Uses:
• helps relieve the local itching and discomfort associated with hemorrhoids • temporarily relieves burning and shrinks hemorrhoidal tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritatedanorectal surface to help make bowel movements less painful.
Warnings:
For rectal 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 prostate gland unless directed by a doctor
Ask A Doctor Or Pharmacist Before Use
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
• children under 12 years of age: ask a doctor
Stop Use And Ask Doctor If
• bleeding occurs • condition worsens or does not improve within 7 days
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. (1-800-222-1222)
Other Information:
store at 20° - 25°C (68° - 77°F)
Inactive Ingredients:
methylparaben, propylparaben, topical starch
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 insertion of this product. • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
• hold suppository with rounded end • see illustrations; carefully separate foil tabs by inserting tip of fingernail at end marked “peel
down” • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository • remove exposed
suppository from wrapper • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each
bowel movement.
Intended Use Of The Device
Shrinks Swollen Tissue
• Reduces internal swelling, soothes & protects
• Gives prompt relief from the painful burning, itching & discomfort from hemorrhoids on a temporary basis
Package Label.Principal Display Panel
Suppositories 24count (Pk Ic108 Rev1 Suppositories Box 24ct Page 0001)
* Please review the disclaimer below.
