JIDESHENG HEMORRHOID (WITCH HAZEL, CARTHAMUS TINCTORIS FLOWER BED, CORYDALIS AMBIGUA TUBER, LONGICERA CAPRIFOLIUM CAPRIFOLIUM FLOWER) OINTMENT [NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS

JIDESHENG HEMORRHOID (WITCH HAZEL, CARTHAMUS TINCTORIS FLOWER BED, CORYDALIS AMBIGUA TUBER, LONGICERA CAPRIFOLIUM CAPRIFOLIUM FLOWER) OINTMENT [NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS
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NDC 51849-1250-1
Set ID 18c2ae3f-ffdb-4ab0-b6b8-18683a9e687e
Category HUMAN OTC DRUG LABEL
Packager NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS CO LTD
Generic Name
Product Class
Product Number
Application Number PART346
  • ACTIVE INGREDIENTS

    WITCH HAZEL 1.25%                                                      

    CARTHAMUS TINCTORIUS FLOWER BUD 1.25%          

    CORYDALIS AMBIGUA TUBER 1.25%                

    LONICERA CAPRIFOLIUM FLOWER 0.5%                         

  • PURPOSE

    ASTRINGENT
    VASOCONSTRICTOR
    LOCAL ANESTHETIC
    PROTECTANT

  • USES

    helps relieve local itching and discomfort associated with hemorrhoids

    temporarily shrinks hemorrhoidal tissue and relieves burning

    temporarily provides a coating for relief of anorectal dosconforts

    temporarily protects the inflamed, irritated anorectal surface to help bowel movements less painful

  • WARNINGS

    For external and/or intrarectal 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

    do not exceed the recommended daily dosage unless directed by a doctor

  • STOP USE AND ASK A DOCTOR IF

    bleeding occurs

    condition worses or does not improve within 7 days

    introduction of applicator into the rectum causes additional pain

  • 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. (1-800-222-1222)

  • DIRECTIONS

    cleanse the affected area with an appropriate cleansing wipe or clean tissue paper

    when fist opening the tube, puncture foil seal with top end of cap

    apply to the affected area up to 4 times only, especially at night, in the morning or after each bowel movement

    intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator after each use and replace cover

    also apply ointment to external area

    regular use provides continual therapy for relief of symptoms

    children under 12 year of age: ask a doctor

  • OTHER INFORMATION

    store at 20 -25°C (68 -77°F)

  • INACTIVE INGREDIENTS

    Coptis Chinensis Root, Petrolatum, Mineral Oil, Stearic Acid, Glyceryl Monostearate, Sodium Dodecylbenzenesulfonate, Cetostearyl Alcohol, Water

  • QUESTIONS?

    Call 1 (626)285-1600 Monday through Friday, 9:00 a.m. to 5:30 p.m. P.S.T

  • PRINCIPAL DISPLAY PANEL

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    JIDESHENG HEMORRHOID 
    witch hazel, carthamus tinctoris flower bed, corydalis ambigua tuber, longicera caprifolium caprifolium flower ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51849-1250
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL12.5 mg  in 1000 mg
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0) (CARTHAMUS TINCTORIUS FLOWER BUD - UNII:B86IS274O0) CARTHAMUS TINCTORIUS FLOWER BUD12.5 mg  in 1000 mg
    CORYDALIS AMBIGUA TUBER (UNII: 1DN1EU584R) (CORYDALIS AMBIGUA TUBER - UNII:1DN1EU584R) CORYDALIS AMBIGUA TUBER12.5 mg  in 1000 mg
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) (LONICERA CAPRIFOLIUM FLOWER - UNII:5N1WD9784U) LONICERA CAPRIFOLIUM FLOWER5 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL) 7.5 mg  in 1000 mg
    PETROLATUM (UNII: 4T6H12BN9U) 40 mg  in 1000 mg
    MINERAL OIL (UNII: T5L8T28FGP) 40 mg  in 1000 mg
    STEARIC ACID (UNII: 4ELV7Z65AP) 55 mg  in 1000 mg
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 30 mg  in 1000 mg
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) 10 mg  in 1000 mg
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.4 mg  in 1000 mg
    WATER (UNII: 059QF0KO0R) 744.6 mg  in 1000 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51849-1250-11000 mg in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34605/15/2010
    Labeler - NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS CO LTD (545864816)
    Registrant - NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS CO LTD (545864816)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS CO LTD545864816manufacture(51849-1250)

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