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  5. Label Information: Shopko Hemorrhoidal

FDA Label for Shopko Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - ASK DOCTOR
    5. OTC - ASK DOCTOR/PHARMACIST
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. INDICATIONS & USAGE
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. DOSAGE & ADMINISTRATION
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shopko Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp. 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.

Otc - Active Ingredient



Active ingredients                                                         Purpose

Mineral Oil 14%........................................................Protectant

Petrolatum 74.9%.....................................................Protectant

Phenylephrine HCl 0.25%...................................Vasoconstrictor


Otc - Purpose



Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieves burning
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings



Warnings For external and/or intrarectal use only


Otc - Ask Doctor



Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product do not use more than the recommended daily dosage


Otc - Stop Use



Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not get better within 7 days
  • introduction of the applicator into the rectum causes additional pain

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a physician before use.


Otc - 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.


Indications & Usage



Directions

  • children under 12 years of age: ask a doctor
  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
  • gently dry by patting or blotting with a tissue or a soft cloth before applying
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover from applicator and attach to tube
  • lubricate applicator well, then gently insert applicator into the rectum
  • thoroughly clean applicator and replace protective cover after each use
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • also apply ointment to external area

Storage And Handling



Other information store at 20° to 25°C (68° to 77°F)


Inactive Ingredient



Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax


Dosage & Administration



Distributed By

United Exchange Corp

17211 Valley View Ave

Cerritos, CA 90703

Made in Korea


Package Label.Principal Display Panel



image of carton label - SHOHemOintment

image of carton label - SHOHemOintment


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