SIMPLE PROMISE Simple H Hemorrhoid Relief Cream PHENYLEPHRINE HYDROCHLORIDE PRAMOXINE HYDROCHLORIDE SIMPLE PROMISE PTE LTD FDA Approved 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
FunFoxMeds box
Route
TOPICAL
Applications
M015
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Phenylephrine HCl 0.25% Pramoxine HCl 1% Purpose Vasoconstrictor Local anesthetic
Inactive Ingredients
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.
Strengths
0.25 % 1 %
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
04JA59TNSJ 88AYB867L5
Packaging

Package Labeling: SIMPLE PROMISE Simple H Hemorrhoid Relief Cream, 2oz/56.7g Label

Package Descriptions
  • Package Labeling: SIMPLE PROMISE Simple H Hemorrhoid Relief Cream, 2oz/56.7g Label

Overview

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

Indications & Usage

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

Dosage & Administration

Directions • : 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. Adults

Warnings & Precautions
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. • attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE: 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.
Purpose

Purpose Vasoconstrictor Local anesthetic

Do Not Use

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.

When Using

When using this product • do not exceed the recommended daily dosage unless directed by a doctor. • attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE: In case of bleeding, consult a doctor promptly.

Stop Use & Ask a Doctor

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.

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.


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