0.25 % Phenylephrine Hcl Hemorrhoidal Ointment
FDA Label NDC 52000-438
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product 0.25 % Phenylephrine Hcl Hemorrhoidal (NDC 52000-438). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Mineral Oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
Purpose
Protectant
Protectant
Vasoconstrictor
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 use only.
Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland
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
Stop use and ask a 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 healthcare professional before use
Otc - Keep Out Of Reach Of Children
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 ointment • when first opening the tube, puncture foil seal secured on tube • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum • thoroughly cleanse applicator after each use and replace cover • also apply ointment to external area • regular use provides continual therapy for relief of symptoms • children under 12 years of age: ask a doctor.
Other Information
• store at 20°–25°C (68°–77°F) • do not use if tube seal under cap is broken
Inactive Ingredients
beeswax, ceteareth-20, cetostearyl alcohol, glycerin
Packaging
Hemorrhoidalointment (52000438 2)
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