Label: MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL ointment

  • 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 November 20, 2009

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  • ACTIVE INGREDIENTS

    Mineral oil, 14%

    Petrolatum, USP 71.9%

    Phenylephrine HCI, 0.25%

    Shark liver oil, 3.0%

  • PURPOSE

    Protectant

    Protectant

    Vasoconstrictor

    Protectant

  • USES

    • Temporarily shrinks hemorrhoidal tissue
    • Temporarily relieves itching, burning and discomfort associated with hemorrhoids
  • WARNINGS

    For external and/or intrarectal use only.


    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • 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.
    • do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

    Stop use and ask a doctor if

    • you experience bleeding
    • condition worsens or does not improve within 7 days.
    These may be signs of a serious condition.


    If pregnant or breastfeeding

     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 soft cloth before application of this ointment.
    • Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
    For intrarectal use:
    • Before applying, remove protective cover from applicator. Attach applicator to tube. Lubricate applicator well and then gently insert applicator into the rectum. Thoroughly clean applicator after each use and replace protective cover.
    • Also apply ointment to external area.
    Children under 12 years:  ask a doctor.
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store in a cool place or at room temperature but not over 86° F.
  • INACTIVE INGREDIENTS

    beeswax, benzoic acid, BHA, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, thyme oil, tocopherol, water
  • QUESTIONS


  • PACKAGE INFORMATION

    TRIAD®

    HEMORRHOIDAL
    OINTMENT

    Helps prevent further irritation
    Temporarily shrinks hemorrhoids

    • Soothes itching, burning and discomfort associated with hemorrhoids
    • Temporarily shrinks hemorrhoids
    • For prompt temporary relief
    Net wt.
    2 oz. (56.7 g)

    Manufactured by
    Triad Group, Inc.
    Brookfield, WI 53045
    MADE IN USA
    www.triad-group.net

    DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED.

    carton

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL 
    mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-4536
    Route of AdministrationRECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    light mineral oil (UNII: N6K5787QVP) (light mineral oil - UNII:N6K5787QVP) light mineral oil140 mg  in 1 g
    petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum719 mg  in 1 g
    phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride2.5 mg  in 1 g
    shark liver oil (UNII: 4B24275HEU) (shark liver oil - UNII:4B24275HEU) shark liver oil30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WAX, YELLOW (UNII: 2ZA36H0S2V)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    THYMUS OIL (UNII: M86Z5G7U0L)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-4536-01 in 1 BOX
    156.7 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/01/2005
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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