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  5. Label Information: Hemorrhoidal Starch

FDA Label for Hemorrhoidal Starch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. OTC - ASK DOCTOR/PHARMACIST
    7. OTC - DO NOT USE
    8. STOP USE AND ASK A DOCTOR
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. OTC - QUESTIONS
    16. PACKAGE INFORMATION - REPRESENTATIVE LABEL

Hemorrhoidal Starch Product Label

The following document was submitted to the FDA by the labeler of this product H And P Industries, Inc. Dba Triad Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

Otc - Ask Doctor/Pharmacist





Otc - Do Not Use





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.

Other





Other Information



Store below 86° F (30° C).

Inactive Ingredients



Benzyl alcohol, hydrogenated vegetable oil, tocopheryl acetate

Otc - 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 - 33 1512CVS C B0309

    box - 33 1512CVS C B0309



* Please review the disclaimer below.