Label: 0.25 % PHENYLEPHRINE HCL HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hydrochloride ointment
- NDC Code(s): 52000-438-02
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 8, 2026
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
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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
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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
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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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
0.25 % PHENYLEPHRINE HCL HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-438 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 14 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-438-02 1 in 1 BOX 01/19/2026 1 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 01/19/2026 Labeler - Universal Distribution Center LLC (019180459)
