Label: HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment
- NDC Code(s): 68016-528-00
- Packager: Pharmacy Value Alliance, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
-
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 and/or anorectal 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
When using this product do not exceed the recommended daily dosage unless directed by a doctor
- Stop Use and Ask Doctor if
- If Pregnant or breast-feeding
- Keep out of reach of children
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Directions
Children under 12 years of age: ask a doctor before use
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
- when first opening tube, remove foil seal
- for intrarectal use: remove protective cover from applicator into the rectum
- lubricate applicator well, then gently insert applicator into the rectum
- thoroughly clean applicator and replace protective cover after each use
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- also apply ointment to external area
- Other Information
- Inactive Ingredients
- Distributed by:
- Hemorrhoidal Ointment
- Packaging
-
INGREDIENTS AND APPEARANCE
HEMORRHOIDALOINTMENT
mineral oil, petrolatum, phenylephrine hci ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-528 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 GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) PROPYLPARABEN (UNII: Z8IX2SC1OH) THYME OIL (UNII: 2UK410MY6B) WHITE WAX (UNII: 7G1J5DA97F) PARAFFIN (UNII: I9O0E3H2ZE) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-528-00 1 in 1 BOX 07/19/2016 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 07/19/2016 Labeler - Pharmacy Value Alliance, LLC (101668460) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
