Label: HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine ointment

  • Category: HUMAN OTC DRUG LABEL

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 July 31, 2015

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  • Active Ingredient                    PurposeMineral Oil - 14%                   ProtectantPetrolatum - 71.9%              ProtectantPhenylephrine - 0.25%          Astringent

  • PURPOSE

  • Uses:

    • Helps relieve local itching and discomfort with hemorrhoids.
    • Temporarily shrinks hemorrhoid tissues and relieves burning.
    • Temporarily provides a coating for relief of anorectal discomforts
    • Temporarily protects the inflamed, irritated anorectal surface to hlep make bowel movements less painful
  • Warnings:

    For external and/or intrarectal use only

  • ASK DOCTOR

    Ask a doctor before use if you have

    • Heart disease
    • Thyroid disease
    • Diabetes
    • High Blood pressure
    • Difficulty in urination due to enlargement of the prostate gland
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or a 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 the 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 tissue.
    • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointment
    • Apply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.


    For Intrarectal use

    • Remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert into the rectum.
    • Thoroughly cleanse applicator after each use
    • Also apply ointment to external area
    • Regular use provides continual therapy for relief of symptoms
    • Children under 12 years of age, consult a doctor
  • Other Information:

    Store at room temperature but not over 80­° F
    Lot No. & Exp Date: See tube

  • Inactive Ingredients:

    Beeswax, benzoic acid, BHA, corn oil, glycern, lanolin alcohol, methyparaben, paraffin, propylparaben, shark liver oil, thyme, tocopherol, water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL7.98 g  in 57 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM40.983 g  in 57 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.1425 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    THYME (UNII: CW657OBU4N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-044-0257 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/31/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-044)