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

  • NDC Code(s): 69396-082-02
  • Packager: Trifecta Pharmaceuticals USA LLC
  • 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 January 17, 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 profects 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
    • difficulty 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)

  • Directions

    Adults:

    • When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or with a soft cloth before applying ointment
    • Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • Intrarectal Use: Remove cover from applicator, attach applicator to tube, lubricate applicator well, and gently insert applicator into rectum. thoroughly cleanse applicator after each use and replace cover.
    • Also apply ointment to external area
    • Regular use provides continual therapy for relief of symptoms
    • Children under 12 years of age: ask a doctor
  • Other Information

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

    Questions? Call 1-888-296-9067

  • Distributed By

    CVS Pharmacy Inc.

    One CVS Drive

    Woonsocket, RI 02895

    ©2020 CVS Pharmacy

    CVS.com

    1-800-SHOP CVS

    Made in China

    V-36582

    CVS Quality Money Back guarantee

    This product is not manufactured or distributed by Wyeth LLC, owner of registered trademark Preparation H®

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    CVS Hemorrhoidal Ointment 2oz

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDALOINTMENT 
    mineral oil, petrolatum, phenylephrine hci ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-082
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURETH-23 (UNII: N72LMW566G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-082-021 in 1 BOX06/18/2021
    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 finalpart34606/18/2021
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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