FDA Label for Hemorrohoid Master Cream
View Indications, Usage & Precautions
Hemorrohoid Master Cream 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.
Otc - Active Ingredient
Active Ingredients
Lidocaine 5.00%
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
Other Information
■ Keep away from direct sunlight or heat.
■ Store at room temperature 15°-30°C (59°-86°F).
■ This package is child-resistant. 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.
Inactive Ingredient
Inactive Ingredients
Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Alcohol, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, BHA, BHT, Boswellia Serrata Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylyl Glycol, Carbomer, Carthamus Tinctorius (Safflower) Seed Oil, Centella Asiatica Extract, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hexylene Glycol, Hydroxyethylcellulose, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Myrtus Communis Oil, Panax Ginseng Root Extract, Panthenol, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Punica Granatum Fruit Extract, Pyridoxine HCl, Sodium Citrate, Sodium Metabisulfite, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water, Xanthan Gum, Zinc Oxide
Otc - Purpose
Purpose
Local Anesthetic
Vasoconstrictor
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