FDA Label for Hemorrhoidal
View Indications, Usage & Precautions
Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110 Dba Leader. 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
Phenylephrine HCI 0.25%
Mineral Oil 14%
Petrolatum 74.9%
Purpose
Vasoconstrictor
Protectant
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
Warnings
For external and/or intrarectal use only
Ask doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
Ask doctor before use if you are presently taking a prescription drug for high blood pressure or depression.
Stop Use And Ask Doctor If
- Bleeding occurs
- Condition worsens or does not improve within 7 days
- Introduction of applicator into the rectum causes additional pain
If Pregnant Or Breast-Feeding
Ask a doctor before use
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away (1-800-222-1222) right away
Directions
- Children under 12 years of age; ask doctor before use
- Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe.
- When first opening tube, remove foil seal
- Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use.
- Regular use provides continual therapy for relief of symptoms
- also apply ointment to external area.
Gently dry by patting or blotting with a tissue or soft cloth before applying.
Other Information
- Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol
Distributed By:
Distributed by Cardinal Health
Dublin, Ohio 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
Made in China
Questions Or Comments?
1-888-296-9067
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