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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 31, 2025

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

  • Active ingredient

    Mineral Oil 14%

    Petrolatum 74.9%

    Phenylephrine HCI 0.25%

  • Purpose

    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

    ■ condition worsens or does not improve within 7 days ■ bleeding occurs

    ■ 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 pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
    ■ Apply to affected areas up to 4 times daily.
    ■ EXTERNAL USE: Apply to affected area
    ■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently insert applicator into the rectum ■ Thoroughly clean applicator after each use and replace cover
    Children under 12 years of age: consult a doctor

  • Other information

    ■ Store at 15°C – 30°C (59°F – 86°F)
    ■ Lot No. & Expiry Date: See box or crimp of tube

  • Inactive ingredients

    benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, vitamin E, white wax

  • SPL UNCLASSIFIED SECTION

    READ AND KEEP CARTON FOR COMPLETE INFORMATION

    *This product is not manufactured or distributed by the owners of Preparation H® Hemorrhoidal Ointment.

    Manufactured for: Bionpharma Inc., Princeton, NJ 08540

    GUJ/DRUGS/G/25/2134

    MADE IN INDIA

    L0000812

    R0424

    LOT & EXP.

  • tube carton

    *compare to the active ingredient in Preparation H ® Hemorrhoid Treatment Ointment

    NDC 69452-448-38

    a+ health TM

    hemorrhoidal ointment

    • reduces irritation • with applicator

    dye-free • phthalate-free • fragrance-free

    • relieves both internal and external hemorrhoid symptoms
    • temporarily shrinks swollen hemorrhoidal tissue
    • prompt, soothing relief from painful burning, itching and discomfort

    net wt. 2 oz

    image001

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-448
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CORN OIL (UNII: 8470G57WFM)  
    LANOLIN (UNII: 7EV65EAW6H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    THYME OIL (UNII: 2UK410MY6B)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-448-381 in 1 CARTON04/10/2025
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/10/2025
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176manufacture(69452-448)