Drug Facts
Active Ingredients
Lidocaine 5%
Purpose
Local Anesthetic
Haemorrhoidal Pain Relief Cream
FDA Label NDC 13709-358
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 Haemorrhoidal Pain Relief (NDC 13709-358). 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, uses, warnings, stop use and ask a doctor if you have, stop use and ask a doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves Pain and Itching due to anorectal disorders
When using this product
■ avoid contact with eyes
■ do not exceed recommended dosage unless directed to do so by a doctor
temporarily relieves pain and itching due to anorectal disorders.
Warnings
When Using this Product
- Avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
Stop Use And Ask A Doctor If You Have
- Rectal bleeding occurs
- condition worserns or does not improve within 7 days
- allergic reaction occurs
- redness, irritaion, swelling, pain or other symptoms begin or increase
- symptoms clearup and return within a few days
Stop Use And Ask A Doctor If
Rectal bleeding occurs
condition worserns or does not improve within 7 days
allergic reaction occurs
redness, irritaion, swelling, pain or other symptoms begin or increase
symptoms clearup and return within a few days
Bleeding occurs
■ Condition worsens or does not improve within 7 days
■ An allergic reaction occurs
■ The symptom being treated does not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison control center right away
Directions
Clean the area with mild soap and warm water and rinse thoroughly.
Gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying to the affected area up to six (6) times per day.
Recommended for use by adults and children 12 years and older.
Clean the area with mild soap and warm water and rinse thoroughly.
Gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying to the affected area up to six (6) times per day.
Recommended for use by adults and children 12 years and older.
Other Information
Do not exceed 30°C (86°F). Protect from freezing.
Inacive Ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, purified water.
If Pregnant Or Breast-Feeding
Ask a health professional before use
Package Label
Haemorrhoidal Pain Relief Anorectal Cream
5% Lidocaine
Highest OTC strength licodaine available
Rapid, numbing relief from pain,burning, itching, &discomfort
Net WT 1 OZ (28g)
* Please review the disclaimer below.
