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
- 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 September 27, 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 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
-
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 final part346 05/04/2017 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
