FDA Label for Hemorrhoid Master
View Indications, Usage & Precautions
Hemorrhoid Master Product Label
The following document was submitted to the FDA by the labeler of this product Clinical Resolution Laboratory, 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.
Otc - Active Ingredient
Active Ingredients
Lidocaine 4.00%
Phenylephrine HCl 0.25%
Dosage & Administration
Directions
■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
■ For External Use: Apply externally to the affected area up to 4 times daily.
■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.
Warnings
Warnings:For external and/ or intrarectal use only.
■ If condition worsens or does not improve within 7 days, consult a doctor.
■ Do not exceed the recommended daily dosage unless directed by a doctor.
■ In case of bleeding, consult a doctor promptly.
■ Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult 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.
■ Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
■ Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.
Indications & Usage
Uses
■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.
■ For the temporary relief of pain, burning and soreness.
■ Temporarily shrinks hemorrhoidal tissue.
■ Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.
Otc - Keep Out Of Reach Of Children
■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
■ For External Use: Apply externally to the affected area up to 4 times daily.
■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.
Inactive Ingredient
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, Glycerin, 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, Propylene Glycol, Punica Granatum Extract, Pyridoxine HCl, Retinyl Palmitate, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Zea Mays (Corn) Oil, Zinc Oxide
Otc - Purpose
Purpose
Local Anesthetic
Vasoconstrictor
Other Safety Information
Other Information
■ Keep away from direct sunlight or heat.
■ Store at room temperature 15°-30°C (59°-86°F).
■ Keep out of reach of children.
■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
■ Do not use this product if seal is broken or missing.
Package Label.Principal Display Panel
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