XYRALID HEMORRHOIDAL (HEMORRHOIDAL SUPPOSITORIES) SUPPOSITORY [INNOVUS PHARMACEUTICALS, INC.]

XYRALID HEMORRHOIDAL (HEMORRHOIDAL SUPPOSITORIES) SUPPOSITORY [INNOVUS PHARMACEUTICALS, INC.]
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NDC 57483-410-12, 57483-410-13
Set ID 8a885822-42e7-44e0-82d6-fa967123866e
Category HUMAN OTC DRUG LABEL
Packager Innovus Pharmaceuticals, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • Active ingredients

    Active Ingredients Purpose

    Cocoa butter 88.50%...................................................................Protectant

    Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

  • Uses

    • temporarily shrinks hemorrhoidal tissue
    • temporarily relieves itching, burning, and discomfort associated with hemorrhoids
    • aids in protecting irritated anorectal areas
  • Warnings

    For rectal use only

  • Ask a doctor or pharmacist before use if you are

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

  • 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

  • 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 or condition worsens or does not improve within 7 days

  • If pregnant or breastfeeding

    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.

  • 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 toilet tissue or a soft cloth.

    -remove the wrapper before inserting into the rectum.

    -insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.

    -Children under 12 years of age: consult a doctor

  • Other information

    Store at 20-25oC (68-77oF)

  • Inactive ingredients

    corn starch, methylparaben, propylparaben

  • Purpose

    Protectant

    Vasoconstrictor

  • Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    XYRALID HEMORRHOIDAL 
    hemorrhoidal suppositories suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-410
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER88.5 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.26 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.02 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.02 g  in 100 g
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) 11.2 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57483-410-134 in 1 CARTON03/25/2018
    1NDC:57483-410-1224 g in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/25/2018
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(57483-410)

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