Label: HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment
- NDC Code(s): 69396-020-01, 69396-020-02
- Packager: Trifecta Pharmaceuticals USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
- Warnings
- Stop Use and Ask Doctor if
- If Pregnant or Breast-Feeding
- Keep out of reach of children
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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 bowel movement
- Attach included applicator to tube
- Lubricate applicator tip and gently insert into rectum
- Thoroughly clean applicator after each use and replace cover
Children under 12 years of age: ask a doctor before use
- Other Information
- Inactive Ingredients
- Distributed By:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOIDALOINTMENT
mineral oil, petrolatum, phenylephrine hci ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-020 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 PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) WHITE WAX (UNII: 7G1J5DA97F) THYME OIL (UNII: 2UK410MY6B) LANOLIN (UNII: 7EV65EAW6H) GLYCERIN (UNII: PDC6A3C0OX) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-020-02 1 in 1 BOX 05/04/2017 1 56 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-020-01 1 in 1 BOX 09/14/2020 2 28.4 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 05/04/2017 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
