FDA Label for Dr.seymour Butts Hemorrhoid
View Indications, Usage & Precautions
Dr.seymour Butts Hemorrhoid Product Label
The following document was submitted to the FDA by the labeler of this product Jiangxi Yudexi Pharmaceutical Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 5% Phenylephrine HCl 0.25%
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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