HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment 
Trifecta Pharmaceuticals USA LLC

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.

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Hemorrhoidal Ointment

Drug Facts

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Mineral Oil 14%

Purpose

Protectant

Active Ingredient

Petrolatum 74.9%

Purpose

Protectant

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

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

Stop Use and Ask Doctor if

  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Introduction of applicator into the rectum causes additional pain

If Pregnant or Breast-Feeding

Ask a doctor before use

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

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

  • Store at room temperature 20°-25°C (68°-77°F)
  • Close cap tightly after use

Questions? Call 1-888-296-9067

Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

Distributed By:

Trifecta Pharamceuticals USA, LLC.

101 NE Third Ave. Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Packaging

Hemorrhoid Ointment

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-020-021 in 1 BOX05/04/2017
156 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-020-011 in 1 BOX09/14/2020
228.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/04/2017
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2023
 
Trifecta Pharmaceuticals USA LLC