MAYINGLONG BEZORNIL HEMORRHOIDAL - calamine, petrolatum, phenylephrine hydrochloride ointment 
MAYINGLONG PHARMACEUTICAL GROUP CO LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

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

Purpose
Hemorrhoidal (anorectal) astringent/protectant
Hemorrhoidal (anorectal) protectant
Hemorrhoidal (anorectal) vasoconstrictor

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
For rectal use only

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

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

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

Keep out 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 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.

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 ingredients
Amber, lanolin, pearl, and sodium borate.

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

MAYINGLONG BEZORNIL HEMORRHOIDAL OINTMENT  NDC 30803-001-01  0.353 oz (10 g)IMAGE OF CARTON

MAYINGLONG BEZORNIL HEMORRHOIDAL 
calamine, petrolatum, phenylephrine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30803-001
Route of AdministrationTOPICAL, RECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.4 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.05 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM79.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMBER (UNII: 70J9Z0J26P)  
LANOLIN (UNII: 7EV65EAW6H)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30803-001-0110 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/28/2013
Labeler - MAYINGLONG PHARMACEUTICAL GROUP CO LTD (526823828)
Establishment
NameAddressID/FEIBusiness Operations
MAYINGLONG PHARMACEUTICAL GROUP CO LTD526823828manufacture(30803-001)

Revised: 8/2013
Document Id: 8c7953ed-0a84-48c8-92a7-bfea6d064c55
Set id: 80863615-a588-4178-a329-757f6530431e
Version: 1
Effective Time: 20130828
 
MAYINGLONG PHARMACEUTICAL GROUP CO LTD