FDA Label for Hemorrhoidal Cocoa Butter
View Indications, Usage & Precautions
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- DIRECTIONS:
- INTENDED USE OF THE DEVICE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Hemorrhoidal Cocoa Butter Product Label
The following document was submitted to the FDA by the labeler of this product Neilmed Pharmaceuticals Inc.. 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.
Drug Facts : Active Ingredients (In Each Suppository) :
Cocoa butter 88.44%
Phenylephrine Hydrochloride 0.25%
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
* Please review the disclaimer below.