Other
Hemorrhoid Ointment
Hemorrhoid Ointments
FDA Label NDC 84023-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Yangan Technology Co., Ltd. for the product Hemorrhoid Ointments (NDC 84023-401). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine 5%
Otc - Purpose
Topical Anesthetic
Indications & Usage
Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burnina, itching).
Temporarily reduces the sweling associated with irritated hemorrhoidal tissue and other anorectal disorders.
Warnings
For externaand/or intrarectal use only
Otc - When Using
Do not exceed recommended daily dosage unless directed by a doctor.
Ask a doctor before use if you have:
Allergies to any of the components of this product.
Difficulty in urination due to enlargement of the prostate gland.
Diabetes: Heart Disease : High Blood Pressure Thyroid Disease.
Presently taking a prescription for high blood pressure or depression.
Otc - Stop Use
Condition worsens or does not improve within seven (7) days.
Bleeding occurs.
Introduction of applicator into the rectum causes additional pain.
Otc - Do Not Use
lf pregnant or breast-feeding, ask a health care professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, seek medical help or contact a Poison Contro Center right away.
Dosage & Administration
Children under 12 years of age consult your pediatrician.
Adults: apply to the affected area up to 3 times daily.
Clean affected area with mild soap and 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 tube, lubricate well. then gently 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.
Storage And Handling
Store at 59* to 77*F to avoid melting
Inactive Ingredient
Aloe barbadebsis leaf juice (Aloe vera)
Water
Lecithin (Soybean)
Carbomer
Menthol
Triethanolamine
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
