Label: WALGREENS- hemorrhoidal pain relief ointment

  • NDC Code(s): 0363-6503-01, 0363-6503-02
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2024

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

  • ACTIVE INGREDIENTS

    Mineral oil 14%

    Petrolatum 74.9%

    Phenylephrine HCl 0.25%

  • PURPOSES

    Protectant

    Protectant

    Vasoconstrictor

  • 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 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.

  • 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.
    • when first opening the tube, puncture foil seal with top end of cap
    • 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 20-25°C (68-77°F)

  • INACTIVE INGREDIENTS

    benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

  • QUESTIONS OR COMMENTS?

    1-800-925-4733

  • 28 g Carton Label

    Carton Label

  • 28 g Tube Label

    Tube Label

  • 57 g Carton Label

    Carton Label

  • 57 g Tube Label

    Tube Label

  • INGREDIENTS AND APPEARANCE
    WALGREENS 
    hemorrhoidal pain relief ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    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
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    THYME (UNII: CW657OBU4N)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Coloryellow (smooth yellow ointment) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6503-011 in 1 CARTON03/01/2004
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0363-6503-021 in 1 CARTON03/01/2004
    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 DrugM01503/01/2004
    Labeler - Walgreens (008965063)
    Registrant - Unipack LLC (116015769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(0363-6503)