FDA Label for Mayinglong Bezornil Hemorrhoidal

The following document was submitted to the FDA by the labeler of this product Mayinglong Pharmaceutical Group 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.

Otc - Active Ingredient

Active ingredients
Calamine 10.5%
Petrolatum 79.25%
Phenylephrine hydrochloride 0.25%

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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