FDA Label for Maximum Strength Hemorrhoidal Cream With Aloe
View Indications, Usage & Precautions
Maximum Strength Hemorrhoidal Cream With Aloe Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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.
Active Ingredient
Glycerin 14.4%
Phenylephrine HCI 0.25%
Pramoxine HCI 1%
White Petrolatum 15%
Purpose
Protectant
Vasoconstrictor
Local Anesthetic
Protectant
Uses
For temporary relief of pain, soreness and burning.
Helps relieve the local itching and discomfort associated with hemorrhoids
Temporarily shrinks hemorrhoidal tissue.
Temporarily provides a coating for relief of anorectal discomforts
Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Stop Use And Ask A Doctor
Bleeding occurs
Condition worsens or does not improve within 7 days
An allergic reaction develops
The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If Pregnant Or Breast Feeding
Ask doctor 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, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.
When first opening the tube, remove the foil seal.
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
For application in the lower anal canal; remove cover from applicator. Attach applicator to tube. Lubricate applicator well, then gently insert applicator pathway into anus.
Thoroughly cleanse applicator after each use and replace cover.
Children under 12 years of age: ask a doctor
Warnings
For External Use Only
Ask doctor brfore use if you have
Heart Disease
High blood pressure
Thyroid Disease
Diabetes
Difficulty urinating due to an enlarged prostate gland
Ask doctor before use if you arepresently taking a prescription for high blood pressure or depression
When using this product
Do not exceed the recommended daily dosage unless directed by a doctor
Do not put into the rectum by using fingers or any mechanical device or applicator
Other Information
Store at room temperature 20°-25°C (68°-77°F)
This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®
Inactive Ingredients
Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetearyl alcohol, mono and diglycerides, methylparaben, light mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum
Questions Or Comments
Call 1-800-935-2362
Distributed By
CDMA Inc.®
Novi, MI.48375, USA
800-935-2362
www.qualitychoice.com
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