Label: HEMORRHOIDAL- mineral, petrolatum, phenylephrine hydrochloride ointment

  • NDC Code(s): 51316-228-01, 51316-228-02
  • Packager: CVS PHARMACY, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • Drug Facts

  • Active ingredients

    Mineral oil 14%

    Petrolatum 74.9%

    Phenylephrine HCI 0.25%

    Purpose

    Protectant

    Vasoconstrictor

  • Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily shrinks hemorrhoid 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 use only

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist

    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 a 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 health professional 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 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 the 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 68° - 77° F (20° - 25° C)

  • Inactive ingredients

    beeswax, benzoic acid, cetyl alcohol, glycerol, methylparaben, polyoxyethylene lauryl ether, propylparaben, stearyl alcohol

  • Questions?

    Weekdays 9 AM to 4 PM EST 1-800-639-3803

  • Package Labeling: HEMORRHOIDAL OINTMENT, 1oz/28g

    Outer PackageInner Package

  • Package Labeling: HEMORRHOIDAL OINTMENT, 2oz/57g

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    mineral, petrolatum, phenylephrine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-228
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-228-011 in 1 BOX06/15/2022
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51316-228-021 in 1 BOX06/15/2022
    257 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01506/15/2022
    Labeler - CVS PHARMACY, INC (062312574)
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