Active Ingredient
Lidocaine 5% Phenylephrine HCl 0.25%
Dr.seymour Butts Hemorrhoid Ointment
FDA Label NDC 85248-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Dr.seymour Butts Hemorrhoid (NDC 85248-018). 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, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic，Vasoconstrictor
Use
Temporarily shrinks hemorrhoidal tissue and relieves pain, soreness,
burning, itching, and discomfort associated with hemorrhoids.
Warnings
For external use only Allergy alert: do not use if you have a history of allergy to amide-type
local anesthetics (e.g., lidocaine).
Do Not Use
• if the tube seal is broken or missing • in children under 12 years of age
unless directed by a doctor • for more than 7 days unless directed by a
doctor
When Using
• avoid contact with eyes • do not exceed the recommended dosage
unless directed by a doctor • do not put this product into the rectum (use
the applicator as directed) • if introduction of applicator causes additional
pain, stop use and ask a docto
Stop Use
• bleeding occurs • condition worsens or does not improve within 7 days
• redness, irritation, swelling, pain, or rash develops
If pregnant or breast-feeding, ask a health professional before use.
Ask Doctor
• heart disease, high blood pressure, thyroid disease, or diabetes •
difficulty urinating due to an enlarged prostate • allergies to amide-type
local anesthetics
Keep Oot 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 with mild soap and
warm water, rinse thoroughly, and gently dry. Apply to the affected area
up to 4 times daily, especially at night, in the morning, and after each
bowel movement. To use applicator: lubricate applicator; gently insert
partway into the anal canal and apply a small amount. Clean applicator
after each use.
Children under 12 years of age: ask a doctor.
Other Information
Store at 20–25°C (68–77°F).
Inactive Ingredients
Purified Water，Witch Hazel Extract, Aloe Vera Extract, Boswellia serrata Extract, Sophora，
japonica Extract, Calendula Extract, Centella asiatica Extract, Vitamin E
(Tocopherol), Tocopheryl Acetate, Petrolatum USP, Shea Butter, Glycerin,
Caprylic/Capric Triglycerides (MCT), Cetearyl Alcohol, Glyceryl Stearate,
PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin.
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