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  5. Label Information: Hemorrhoid Master

FDA Label for Hemorrhoid Master

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. STOP USE AND ASK A DOCTOR
    6. WHEN USING THIS PRODUCT
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE
    9. KEEP OUT OF REACH OF CHILDREN:
    10. DIRECTIONS
    11. FOR INTRARECTAL USE:
    12. INACTIVE INGREDIENTS
    13. PACKAGE LABELING:

Hemorrhoid Master Product Label

The following document was submitted to the FDA by the labeler of this product Ebanel Laboratories, Inc. 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



Lidocaine 4.00%

Phenylephrine HCl 0.25%


Purpose



Analgesic (Pain Relief)

(Vasoconstrictor)


Uses



  • Helps relieve the anorectal itching and discomfort in the perianal area.
  • Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders.
  • Temporarily shrinks hemorrhoidal tissue.

Warnings



For external and or intrarectal use only.


Stop Use And Ask A Doctor



  • If condition worsens or does not improve within 7 days.
  • in case of bleeding. 
  • if allergic reaction to product occurs. If the symptoms being treated does not subside or if redness. irritation, swelling, pain, or other sympoms develop or increase.

When Using This Product



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


Do Not Use



this product 

  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
  • with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult doctor promptly.

Ask A Doctor Before Use



if you are

  • presently taking a prescription drug for high blood pressure or depression.

Keep Out Of Reach Of Children:



If swallowed, seek medical help or contact a Poison Control Center immediately.


Directions



Adults: Apply to the affected area up to 3 times dialy.

  • Children under 12 years of age: consult a doctor.
  • When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry (patting or blotting) with tissue or soft cloth before use.
  • To use dispensing cap, attach it to tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

For Intrarectal Use:



Attach applicator to tube. Lubricate well, then gently insert applicator into the rectum.

For External use: Do not put this proudct into the rectum using fingers or any mechanical device.


Inactive Ingredients



Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Cholesterol, Diisopropyl Sebacate, Dimethyl Isosorbide, Dodecane, Ethoxydiglycol, Ethylhexylglycerin, Hexylene Glycol, Hydrocortisone, Isododecane, Isopropyl Myristate, Lecithin, Mentha Piperita (Peppermint) Oil, Microcrystalline Wax, Mineral Oil, Octyldodecanol, Panax Ginseng Root Extract, PEG-8 Dimethicone, Petrolatum, Phenoxyethanol, Phospholipids, Polyethylene, Polysorbate 80, Propylene Glycol, Punica Granatum Extract, Pyridoxine HCl, Retinyl Palmitate, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Zea Mays (Corn) Oil, Zinc Oxide.


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