Label: HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride suppository

  • Category: HUMAN OTC DRUG LABEL

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 December 21, 2021

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  • Active Ingredients (per suppository)

    Cocoa butter 88.44 %

    Phenylephrine hydrochloride 0.25 %

  • Purpose

    Protectant

    Vasoconstructor

  • Uses

    • temporarily shrinks hemorrhoidal tissues
    • gives temporary relief to the 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

    presently taking a prescription drug for high blood pressure or depression

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • 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
    • in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

    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

    • detach one suppository from the strip. 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 doctor
  • Other Information

    Store at room temperature or in a cool place but not over 80° F

  • Inactive ingredients

    methylparaben, propylparaben, starch

  • PRINCIPAL DISPLAY PANEL

    Label 1

    Label 2

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    cocoa butter, phenylephrine hydrochloride suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1021
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER1768.8 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70795-1021-212 in 1 BOX03/29/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70795-1021-424 in 1 BOX04/22/2017
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/29/2017
    Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)
    Registrant - GRAXCELL PHARMACEUTICAL, LLC. (056556923)
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