Simple Promise Simple H Hemorrhoid Relief Cream
FDA Label NDC 83311-335
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Simple Promise Pte Ltd for the product Simple Promise Simple H Hemorrhoid Relief Cream (NDC 83311-335). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, ask a doctor or pharmacist before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
Purpose
Vasoconstrictor
Local anesthetic
Uses
• for temporary relief of pain, soreness and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoid tissue
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings
For external use only
Do Not Use
this product if you have
• heart disease • high blood pressure • thyroid disease • diabetes • 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.
When Using This Product
• do not exceed the recommended daily dosage unless directed by a doctor.
• FOR INTRARECTAL USE: attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum.
In case of bleeding, consult a doctor promptly.
Stop Use And Ask A Doctor If
• condition worsens or does not improve within 7 days • an allergic reaction develops • the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
•
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 cream.
• when first opening the tube, puncture foil seal with top end of cap
• apply externally or in the lower portion of the anal canal only
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement Children under 12 years of age: ask a doctor.
Other Information
• store at 20-25°C (68-77°F)
• do not use if printed safety seal on cap is broken or missing
Inactive Ingredients
Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Dimethicone, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel), Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.
Package Labeling: Simple Promise Simple H Hemorrhoid Relief Cream, 2Oz/56.7G
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