Label: HEMO FIN- petrolatum 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 September 10, 2012

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  • Active ingredient

    Petrolatum (93.3%)

  • Purpose

    Hemorrhoidal ointment

  • Uses

    • Provides temporary relief from skin irritations
    • Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
    • Temporarily protects irritated areas
    • Temporarily relieves burning
    • Temporarily provides a coating for relief of anorectal discomforts
    • Temporarily protects the inflamed, irritated, anorectal surface from irritation and abrasion during bowel movement
    • Temporarily protects inflamed perianal skin
    • Temporarily relieves symptoms of perianal skin irritation
  • Warnings

    For external and/or intrarectal use only

    If condition worsens or does not improve within 7 days, consult a physician

    Do not exceed the recommended daily dosage unless directed by a doctor

    In case of bleeding, consult a physican promptly


  • Do not use

    this product with an applicator if the introduction of the applicator into the rectum causes additional pain.  Consult a doctor promptly.

  • 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 with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate                 cleansing wipe before applying ointment.
    • Apply liberally to affected area as often as necessary.
    • Intrarectal Use: attach applicator to tube, lubricate applicator well and gently insert applicator into rectum.  Thoroughly cleanse applicator after each use.

  • Inactive Ingredients

    Aloe Vera, Iodine, Okra, Oleic Acid, Sage
  • For Questions or Comments:

    PDmerc.com

  • Distributed by

    P D Merc, LLC

    1581 W 49th St #191

    Hialeah, FL 33012

    NDC 50211-001-01

  • PRINCIPAL DISPLAY PANEL

    Hemo-Fin

    Hemorrhoidal Oitment

    Net Wt. 1 oz. (28 g)

    HemoFin20120910.jpg

    Hemo Fin Hemorrhoidal Ointment r1

    HemoFin20120910.jpg

  • INGREDIENTS AND APPEARANCE
    HEMO FIN 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50211-001
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum93.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Iodine (UNII: 9679TC07X4)  
    Okra (UNII: 51ME2L7STL)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    Sage (UNII: 065C5D077J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50211-001-0128 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/10/2012
    Labeler - PD MERC LLC (078424706)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farmaco Drogueria Lequc, S.A. de C.V.814861357manufacture(50211-001)
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