Label: HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hci ointment

  • NDC Code(s): 63868-684-02
  • Packager: Chain Drug Marketing Association Inc.
  • 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 May 23, 2023

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  • 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 intrarectal 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.

  • Ask doctor before use

    Ask doctor before use if you are presently taking a prescription drug for high blood pressure.

    Ask doctor before use if you have:

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

  • 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 each bowel movement.
    • attach included applicator to tube
    • lubricate applicator tip and gently insert into the rectum.
    • thoroughly clean applicator after each use and replace cover.
    • Children under 12 years of age; ask doctor before use
  • Other Information

    • Store at room temperature 20º-25ºC (68º-77ºF)
  • Inactive Ingredients

    Beeswax, Benzoic Acid, Cetyl alcohol, Glycerin, Methylparaben, Laureth-23, Propylparaben, Stearyl alcohol

  • Questions or Comments?

    1-800-935-2362

  • Distributed By

    Distributed By CDMA Inc.

    43157 W 9 Mile Road

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 800-935-2362

    Product of PRC

    This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H.

  • Packaging

    hemorrhoid-ointment 2oz

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hci ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-684
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    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
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-684-021 in 1 BOX08/14/2020
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/14/2020
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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