Label: MAYINGLONG BEZORNIL HEMORRHOIDAL- calamine, petrolatum, phenylephrine hydrochloride ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 30803-001-01 - Packager: MAYINGLONG PHARMACEUTICAL GROUP CO LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 28, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAYINGLONG BEZORNIL HEMORRHOIDAL
calamine, petrolatum, phenylephrine hydrochloride ointmentProduct 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)