Active Ingredient
Glycerol 14.4%
Phenylephrine HCI 0.25%
Pramoxine HCI 1%
Petrolatum 15%
Hemorrhoidal Cream With Aloe Cream
FDA Label NDC 83324-044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Hemorrhoidal Cream With Aloe (NDC 83324-044). 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 active ingredient, purpose, uses, stop use and ask a doctor, if pregnant or breast feeding, keep out of reach of children, directions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Protectant
Vasoconstrictor
Local Anesthetic
Protectant
Uses
Helps relieve the local itching and discomfort associated with hemorrhoids
Temporarily shrinks hemorrhoidal tissue and relieves burning
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.
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
Warnings
For External Use Only
Ask doctor brfore use if you have
Heart Disease
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, cetyl alcohol, mono and diglycerides, methylparaben, 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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