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
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 2, 2023
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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 final part346 07/19/2016 Labeler - Pharmacy Value Alliance, LLC (101668460) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
