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  5. Label Information: Simple Promise Simple H Hemorrhoid Relief Cream

FDA Label for Simple Promise Simple H Hemorrhoid Relief Cream

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PACKAGE LABELING: SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM, 2OZ/56.7G

Simple Promise Simple H Hemorrhoid Relief Cream Product Label

The following document was submitted to the FDA by the labeler of this product Simple Promise Pte Ltd. 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.

Drug Facts




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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