Otc - Active Ingredient
Lidocaine 4%..................................................Local Anesthetic
Phenylephrine Hydrochloride 0.25%...............Vasoconstrictor
Hemorrhoidal-ointment
FDA Label NDC 82433-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rrhoid Rage for the product Hemorrhoidal-ointment (NDC 82433-101). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Local anesthetic, Vasoconstrictor
Indications & Usage
-Helps relieve the pain, itching, and burning associated with hemorrhoids.
-Temporarily reduces the swelling associated with irritated hemorrhoidal
tissue and other anorectal disorders.
-Temporarily provides a coating for relief of anorectal discomforts.
-Temporarily protects irritated areas and inflamed perianal skin.
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
-Avoid contact with eyes.
-Do not exceed recommended daily dosage unless directed by a doctor.
-Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop use and ask a doctor if
-Bleeding occurs.
-Condition worsens or does not improve within 7 days.
-Allergic reaction occurs to ingredients in this product.
-Symptom being treated does not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase.
If pregnant or breastfeeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.
Dosage & Administration
-When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
-Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.
-Children under 12 years of age: consult a doctor.
Other information
-Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).
Inactive Ingredient
aloe extract AQ, balsam fir, butylated hydroxyanisol, glycerin, lanolin alcohols, lanolin USP,
magnesium sulfate, methyl paraben, mineral oil, petrolatum, propylparaben, witch hazel, white
bees wax.
* Please review the disclaimer below.
