Active Ingredient
Phenylephrine HCI 0.25%
Mineral Oil 14%
Petrolatum 74.9%
Hemorrhoidal Ointment
FDA Label NDC 83324-045
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 Inc. for the product Hemorrhoidal (NDC 83324-045). 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, warnings, stop use and ask doctor if, if pregnant or breast-feeding, keep out of reach of children, ask doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 arepresently taking a prescription drug for high blood pressure.
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.
Ask Doctor Before Use
Ask doctor before use if you are presently taking a prescription drug for high blood pressure.
Ask doctor before use if you have:
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Directions
- Adults and children 12 years of age and older for topical use:
- Clean the affected area and pat or dab dry before applying ointment.
- apply to the affected area up to 4 times daily, especially after each bowel movement.
- attach included applicator to tube
- lubricate applicator tip and gently insert into the rectum.
- thoroughly clean applicator after each use and replace cover.
- Children under 12 years of age; ask doctor before use
Other Information
- Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Beeswax, Benzoic Acid, Cetyl alcohol, Glycerin, Methylparaben, Laureth-23, Propylparaben, Stearyl alcohol
Questions Or Comments?
1-800-935-2362
Distributed By
Distributed By CDMA Inc.
43157 W 9 Mile Road
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
Product of PRC
This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H.
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