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HemorrhoidalOintment by Trifecta Pharmaceuticals Usa Llc

Medically reviewed on November 20, 2017

Dosage form: ointment
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 0.25g in 100g, MINERAL OIL 14g in 100g, PETROLATUM 74.9g in 100g
Labeler: Trifecta Pharmaceuticals Usa Llc
NDC Code: 69396-020

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.

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 protects 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 20º-25ºC (68º-77ºF)
  • 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 Pharmaceuticals USA, LLC

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Packaging

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
MINERAL OIL (MINERAL OIL) MINERAL OIL14 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM74.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
WHITE WAX 
PARAFFIN 
THYME OIL 
LANOLIN 
GLYCERIN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:69396-020-051 TUBE in 1 BOX
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/29/2016
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

 
Trifecta Pharmaceuticals Usa Llc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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