Otc - Active Ingredient
Active ingredients
Calamine 10.5%
Petrolatum 79.25%
Phenylephrine hydrochloride 0.25%
Mayinglong Bezornil Hemorrhoidal
FDA Label NDC 30803-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mayinglong Pharmaceutical Group Co Ltd for the product Mayinglong Bezornil Hemorrhoidal (NDC 30803-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Hemorrhoidal (anorectal) astringent/protectant
Hemorrhoidal (anorectal) protectant
Hemorrhoidal (anorectal) vasoconstrictor
Indications & Usage
Uses
temporarily helps relieve:
anorectal burning, itching, and discomfort associated with hemorrhoids
temporarily:
reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
shrinks hemorrhoidal tissue
protects inflamed perianal skin and irritated areas
Warnings
Warnings
For rectal use only
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
Otc - When Using
When using this product
in case of bleeding; consult a doctor promptly
do not exceed the recommended daily dosage unless directed by a doctor
do not use with an applicator if the introduction of the applicator into the rectum causes
additional pain. Consult a doctor promptly.
Otc - Stop Use
Stop use and ask a doctor if
condition worsens
symptoms do not improve within 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
For external hemorrhoids, apply a small amount of ointment directly to the affected area up to 4 times daily.
FOR INTRARECTAL USE (internal hemorrhoids): Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Squeeze a small amount (2 g) of the ointment into the rectum. Remove and discard used applicator. Apply to the affected area up to 4 times daily.
children under 12 years of age: consult a doctor.
Storage And Handling
Other information
keep container tightly closed
store at room temperature 20 - 25° C (68 - 77° F)
do not use if the physical properties of this product have changed
Inactive Ingredient
Inactive ingredients
Amber, lanolin, pearl, and sodium borate.
Otc - Questions
Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm
Package Label.Principal Display Panel
MAYINGLONG BEZORNIL HEMORRHOIDAL OINTMENT NDC 30803-001-01 0.353 oz (10 g)
Image Of Carton (Box)
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