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HemorrhoidalOintment by Pharmacy Value Alliance, LLC

Medically reviewed on November 10, 2017

Dosage form: ointment
Ingredients: MINERAL OIL 14g in 100g, PETROLATUM 74.9g in 100g, PHENYLEPHRINE HYDROCHLORIDE 0.25g in 100g
Labeler: Pharmacy Value Alliance, LLC
NDC Code: 68016-528

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 or depression

When using this product do not exceed the recommended daily dosage unless directed by a doctor

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

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 into the rectum
  • lubricate applicator well, then gently insert applicator into the rectum
  • thoroughly clean applicator and replace protective cover after each use
  • 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

Store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Beeswax, benzolc acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, stearyl alcohol

Distributed by:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Hemorrhoidal Ointment
  • Prevents Further Irritation
  • Prompt Soothing Relief from Painful Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal and External Discomfort

Packaging

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-528
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL14 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
LANOLIN 
PROPYLPARABEN 
THYME OIL 
WHITE WAX 
PARAFFIN 
METHYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:68016-528-001 TUBE in 1 BOX
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/19/2016
Labeler - Pharmacy Value Alliance, LLC (101668460)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

 
Pharmacy Value Alliance, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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