Active Ingredients
Lidocaine USP 4%
Phenylephrine HCL USP 0.25%
Hemorrhoidal Relief Cream
FDA Label NDC 73622-3077
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Curetech Skincare for the product Hemorrhoidal Relief Cream (NDC 73622-3077). 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, purpose, 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
Purpose
Lidocaine USP 4%--------------Local Anesthetic
Phenylephrine HCL USP 0.25%--Vasoconstrictor
Uses
- Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
- Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
Warnings
For external 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 recommended daily usage 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
- an allergic reaction develops
- if symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If Pregnant Or Breast-Feeding
ask a healthcare professional before use
Keep Out Of Reach Of Children:
If swallowed, seek medical help or contact a Poison Control Center right away
Directions
- adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
- to use dispensing cap, attach it to the tube, lubricate well, then gentle insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly
- apply to affected area upto 4 times daily, especially at night, when waking up and after each bowel movement
Children under 12 years of age: ask a doctor
Other Information
- store at 59 to 77 F to avoid melting
Inactive Ingredients
.Alpha.-Tocopherol Acetate, Aloe Vera Leaf, Asian Ginseng, Calendula officinalis Flower, Chamomile, Chlorocresol, Cholecalciferol, Coconut Oil, Corn Oil, Dimethicone, Fragrance, Hyaluronate Sodium, Hydrocortisone, Lysine Hydrochloride, menthol, Mineral Oil, Petrolatum, Propylene Glycol, Pyridoxine Hydrochloride, Sunflower Oil, Tricaprilin, Vitamin A Palmitate, yellow Wax, Zinc Oxide
* Please review the disclaimer below.
