MAYINGLONG BEZORNIL HEMORRHOIDAL- calamine, petrolatum, phenylephrine hydrochloride ointment

MAYINGLONG BEZORNIL HEMORRHOIDAL by

Drug Labeling and Warnings

MAYINGLONG BEZORNIL HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by MAYINGLONG PHARMACEUTICAL GROUP CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression

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.

STOP USE

Stop use and ask a doctor if
condition worsens
symptoms do not improve within 7 days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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 - 25º C (68 - 77º F)
do not use if the physical properties of this product have changed

INACTIVE INGREDIENT

Inactive ingredients
Amber, lanolin, pearl, and sodium borate.

QUESTIONS

Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm

PRINCIPAL DISPLAY PANEL

MAYINGLONG BEZORNIL HEMORRHOIDAL OINTMENT  NDC: 30803-001-01  0.353 oz (10 g)

INGREDIENTS AND APPEARANCE

MAYINGLONG BEZORNIL HEMORRHOIDAL 
calamine, petrolatum, phenylephrine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30803-001
Route of Administration	TOPICAL, RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10.4 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.05 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	79.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMBER (UNII: 70J9Z0J26P)
LANOLIN (UNII: 7EV65EAW6H)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30803-001-01	10 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/28/2013

Labeler - MAYINGLONG PHARMACEUTICAL GROUP CO LTD (526823828)

Establishment
Name	Address	ID/FEI	Business Operations
MAYINGLONG PHARMACEUTICAL GROUP CO LTD		526823828	manufacture(30803-001)