Label: HEMORRHOIDAL STARCH- starch suppository

  • 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 December 31, 2009

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  • ACTIVE INGREDIENT

    Topical starch, 51%

  • PURPOSE

    Protectant

  • USE

    • Provides temporary relief of the itching, burning and discomfort associated with hemorrhoids and other anorectal disorders
    • Provides a coating to protect irritated tissue
  • WARNINGS

    For rectal use only.

    When using this product

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




    Stop use and ask a doctor

    • in case of bleeding
    • if condition worsens or does not improve within 7 days.


    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:
    • When practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly.
    • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
    • Detach one suppository from strip of suppositories.
    • Remove film before inserting into the rectum by holding the suppository upright. Carefully separate film by inserting tip of fingernail at film split.
    • Carefully peel film slowly and evenly down both sides to expose suppository
    • Avoid excessive handling of suppository, which is designed to melt at body temperature. If suppository seems soft, hold in film wrapper under cold water for 2 or 3 minutes.
    • Insert one suppository rectally up to 6 times daily or after each bowel movement
    Children under 12 years: ask a doctor.
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store below 86° F (30° C).
  • INACTIVE INGREDIENTS

    benzyl alcohol, hydrogenated vegetable oil, tocopheryl acetate
  • QUESTIONS


  • PACKAGE INFORMATION - REPRESENTATIVE LABEL

    Compare to the active ingredient in TUCKS®*

    HEMORRHOIDAL
    SUPPOSITORIES
    TOPICAL STARCH

    • Relieves itching, burning and discomfort
    • Protects and soothes irritated tissue
    12 SUPPOSITORIES

    *This product is not manufactured or distributed by Pfizer consumer Healthcare, Inc., owner of the registered trademark TUCKS®.

    box

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL STARCH 
    starch suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-1512
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ) STARCH, CORN0.51 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FAT, HARD (UNII: 8334LX7S21)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-1512-112 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/01/2006
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
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