Label: HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment
- NDC Code(s): 69396-133-20
- 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 June 14, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- 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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
- Introduction of applicator into the rectum causes additional pain
- Warnings
- Stop Use and Ask Doctor if
- If Pregnant or Breast-Feeding
- Keep out of reach of children
- When using this product
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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 and attach to tube
- Lubricate applicator well, then gently insert applicator into rectum
- Thoroughly clean applicator and replace protective cover after each use
- Clean the affected area and pat or dab dry before applying ointment
- 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
- Questions
- 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:69396-133 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 BENZOIC ACID (UNII: 8SKN0B0MIM) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL ALCOHOL (UNII: 936JST6JCN) LAURETH-15 (UNII: 002FR4N8OV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-133-20 1 in 1 BOX 06/01/2023 1 56.8 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 06/01/2023 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
