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  5. Label Information: Hemorrhoidalcreampro

FDA Label for Hemorrhoidalcreampro

View Indications, Usage & Precautions

Table of Contents

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

Hemorrhoidalcreampro Product Label

The following document was submitted to the FDA by the labeler of this product Astonea Labs Private Limited. 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.

Other



Drug Facts


Otc - Purpose



Mineral Oil (14% w/w)............................................. Skin Protectant

Petrolatum (74.9% w/w)........................................... Skin Protectant


Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor


Indications & Usage



Uses

  • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
  • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

Warnings



Warnings

For external use only


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

Otc - Ask Doctor/Pharmacist



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


When Using This Product



  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional 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.


Dosage & Administration



Directions

  • Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
  • To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
  • Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
  • Children under 12 years of age: ask a doctor

Storage And Handling



Other information

store at 20-25°C (68-77°F)


Inactive Ingredient



Inactive ingredients

Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax


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