Label: HEMOPROPIN HEMORRHOIDAL- lanolin, 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 July 3, 2018

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  • Drug Facts

  • Active Ingredient

    Lanolin 17.76%

    Petrolatum 71.2%

    Purpose

    Hemorrhoidal Protectant

  • Uses

    • helps relieve itching and discomfort associated with hemorrhoids and inflamed hemorrhoidal tissues
    • temporarily protects irritated areas
    • temporarily relieves burning
    • temporarily protects inflamed, irritated anorectal surface to help make bowel movements less painful
  • Warnings

    For rectal use only.

    When using this product

    do not exceed the recommended daily dosage unless directed by doctor.

    Stop use and consult a doctor if:

    • condition worsens or does not improve within 7 days
    • the introduction of the applicator into the rectum causes additional pain or bleeding occurs

    If pregnant or breastfeeding,

    consult a health care 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 with mild soap and warm water and rinse thoroughly; gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • Apply externally to the affected area up to 6 times daily or after each bowel movement
    • FOR INTRARECTAL USE: attach applicator to tube; lubricate applicator well, then gently insert applicator into the rectum
    • Children under 12 years of age: consult a doctor
  • Other information

    • store in a dry and cool place
  • Inactive ingredients

    Alcohol, propolis wax, roman chamomile, water

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    HEMOPROPIN HEMORRHOIDAL 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71952-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN17.76 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM71.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71952-010-001 in 1 BOX07/01/2018
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/01/2018
    Labeler - Bee Right LLC (080988303)
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