Label: HEMORRHOIDAL- pain relief ointment

  • NDC Code(s): 13709-319-01
  • Packager: NeilMed Pharmaceuticals Inc.
  • 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 August 22, 2023

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

  • Drug Facts

    Active Ingredients

    Mineral oil 14%

    Petrolatum 74.9%
    Phenylephrine Hydrochloride 0.25%

  • PURPOSE

    Active Ingredients Purpose
    Mineral oil 14% ..................................................................... Protectant
    Petrolatum 74.9%................................................................. Protectant
    Phenylephrine Hydrochloride 0.25% ...............................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:

    Warnings: For external and/or intrarectal use only

  • Ask a doctor before use if you have:

    Ask a doctor before use if you have:

    􀁑􀀃Heart disease 􀁑􀀃High blood pressure 􀁑􀀃Thyroid disease 􀁑􀀃Diabetes
    􀁑􀀃Difficulty in urination due to enlargement of prostate gland.

  • Ask a doctor or pharmacist before use

    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 doctor if:

    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,

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

    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.

    􀁑􀀃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 15°C - 30°C (59°F - 86°F).

  • Inactive ingredients:

    Benzoic acid, butylated hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol acetate, white wax

  • TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

    TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

  • OTHER SAFETY INFORMATION

    Important: Please do not discard this printed box and any enclosed printed material. The inside final
    product may not have all the details you require for the ongoing use of the product.

  • PRINCIPAL DISPLAY PANEL

    Hemorrhoidal Ointment

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    pain relief ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-319
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LANOLIN (UNII: 7EV65EAW6H)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    CORN OIL (UNII: 8470G57WFM)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    THYME (UNII: CW657OBU4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-319-011 in 1 CARTON08/22/2023
    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 finalM01508/22/2023
    Labeler - NeilMed Pharmaceuticals Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc.799295915manufacture(13709-319)