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

  • NDC Code(s): 70000-0046-1
  • Packager: Cardinal Health 100, 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 21, 2020

If you are a consumer or patient please visit this version.

  • 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 or depression.

  • 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 (1-800-222-1222) right away

  • Directions

    • Children under 12 years of age; ask 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
    • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
    • For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use.
    • Regular use provides continual therapy for relief of symptoms

    • also apply ointment to external area.
  • Other Information

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

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

  • Distributed by:

    Distributed by Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    1-800-200-6313

    Essential to Care™ since 1979

    Made in China

  • Questions or Comments?

    1-888-296-9067

  • Packaging

    5983540 CAH LDR Hemorrhoidal Ointment 2oz

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hci ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0046
    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:70000-0046-11 in 1 BOX05/14/2020
    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 finalpart34605/14/2020
    Labeler - Cardinal Health 100, Inc. (097537435)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)