Label: MA YING LONG HEMORRHOIDAL (moschus artifactus, bovis calculus artifactus, margarita, borneolum syntheticum, succinum, calamina- calcined, borax ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69396-006-20 - Packager: Trifecta Pharmaceuticals Usa Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 23, 2016
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- Drug Facts
- Active Ingredients
- Purpose
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Use: Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue and relieves burning. Temporarily provides a coating for relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.
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WARNINGS
Warnings: For external and/or intrarectal use only. Not for oral use. Avoid spicy or sour foods when using this product. If pregnant, please consult a health professional. Keep this and all drugs out of reach of children. Stop using and consult a doctor, if bleeding occurs, condition worsens or does not improve within 7 days. Introduction of applicator into the rectum causes additional pain.
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DOSAGE & ADMINISTRATION
Directions:
• Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. • Apply 2 times daily, once in the morning and once in the evening. When used for external hemorrhoids and anal fissure, apply to the affected area directly. • For Intrarectal use: remove cover from applicator, attached applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover.
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- QUESTIONS
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SPL UNCLASSIFIED SECTION
Description: The ointment is for the treatment and relief of itching and discomfort associated with hemorrhoids. In most cases Ma Ying Long Hemorrhoidal ointment can clear heat and toxic material, remove the putrid tissues and promote their regeneration. It is also used to relieve pain and swelling caused by hemorrhoids. The ointment is grey-yellow or pink color, with fragrant smell and has a cool feeling. It is a well-known OTC drug to treat hemorrhoids.
Before using any medication, read all label directions. Keep this carton. It contains important information.
Traditional Chinese Medicine Since 1582
Traditional Chinese Medicine (TCM)
Listed in China Pharmacopoeia (CP)Manufactured by: Ma Ying Long Pharmaceutical Group Co. LTD, Product of China
Registration No. GYZZZ42021920
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067
www.trifecta-pharma.com - Packaging
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INGREDIENTS AND APPEARANCE
MA YING LONG HEMORRHOIDAL
moschus artifactus, bovis calculus artifactus, margarita, borneolum syntheticum, succinum, calamina (calcined), borax ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOSCHUS BEREZOVSKII MUSK SAC RESIN (UNII: Z70MFY52S4) (MOSCHUS BEREZOVSKII MUSK SAC RESIN - UNII:Z70MFY52S4) MOSCHUS BEREZOVSKII MUSK SAC RESIN 0.15 g in 10 g BOS TAURUS GALLSTONE (UNII: 4162LZ0N4O) (BOS TAURUS GALLSTONE - UNII:4162LZ0N4O) BOS TAURUS GALLSTONE 0.1 g in 10 g PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U) (PEARL (HYRIOPSIS CUMINGII) - UNII:A75L5FZ40U) PEARL (HYRIOPSIS CUMINGII) 0.25 g in 10 g BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL 0.2 g in 10 g AMBER (UNII: 70J9Z0J26P) (AMBER - UNII:70J9Z0J26P) AMBER 0.1 g in 10 g ZINC CARBONATE (UNII: EQR32Y7H0M) (ZINC CATION - UNII:13S1S8SF37) ZINC CARBONATE 0.65 g in 10 g SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 0.2 g in 10 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) PETROLATUM (UNII: 4T6H12BN9U) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-006-20 1 in 1 BOX 01/14/2016 1 10 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/14/2016 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163) Establishment Name Address ID/FEI Business Operations MAYINGLONG PHARMACEUTICAL GROUP CO LTD 526823828 manufacture(69396-006)
