Active Ingredient
Mineral Oil 14%
Petrolatum 74.9%
Phenylephrine HCI 0.25%
Hemorrhoidal Ointment
FDA Label NDC 69452-448
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Hemorrhoidal (NDC 69452-448). 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, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, 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
Purpose
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
■ condition worsens or does not improve within 7 days ■ bleeding occurs
■ 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 pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
■ Apply to affected areas up to 4 times daily.
■ EXTERNAL USE: Apply to affected area
■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently insert applicator into the rectum ■ Thoroughly clean applicator after each use and replace cover
■
Children under 12 years of age: consult a doctor
Other Information
■ Store at 15°C – 30°C (59°F – 86°F)
■ Lot No. & Expiry Date: See box or crimp of tube
Inactive Ingredients
benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, vitamin E, white wax
Other
READ AND KEEP CARTON FOR COMPLETE INFORMATION
*This product is not manufactured or distributed by the owners of Preparation H® Hemorrhoidal Ointment.
Manufactured for: Bionpharma Inc., Princeton, NJ 08540
GUJ/DRUGS/G/25/2134
MADE IN INDIA
L0000812
R0424
LOT & EXP.
Tube Carton
*compare to the active ingredient in Preparation H ® Hemorrhoid Treatment Ointment
NDC 69452-448-38
a+ health TM
hemorrhoidal ointment
• reduces irritation • with applicator
dye-free • phthalate-free • fragrance-free
• relieves both internal and external hemorrhoid symptoms
• temporarily shrinks swollen hemorrhoidal tissue
• prompt, soothing relief from painful burning, itching and discomfort
net wt. 2 oz
Image001 (Image001)
* Please review the disclaimer below.
