Label: LONAZEM- menthol,petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2024

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

  • Active Ingredients

    Menthol 0.1%
    Petrolatum 80%

  • Purpose

    Menthol…….Antipruritic
    Petrolatum…..Protectant

  • Uses

    • Helps relieve the itching and discomfort associated with hemorrhoids, inflamed hemorrhoidal tissues, anorectal disorders and anorectal inflammation
    • Temporarily protects irritated areas
    • Temporarily provides a coating for relief of anorectal discomforts
    • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
    • Temporarily relieves the symptoms of perianal skin irritation
    • Temporarily protects inflamed perianal skin
    • For the temporary relief of pain or burning
    • May provide a cooling sensation
  • Warnings

    • For external and/or intrarectal use only
    • When using this product

    if condition worsens or does not improve within 7 days, consult a doctor


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


    in case of bleeding, consult a doctor promptly

    • Do not insert the applicator into the rectum if it causes additional pain. Consult a doctor promptly.

    If Pregnant or Breastfeeding, ask a healthcare provider before using.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by blotting or patting with a tissue or a soft cloth before applying ointment.
    • Apply to the affected area up to 6 times daily, especially at night, in the morning or after ' each bowel movement.
    • EXTERNAL USE: Apply to external anal area.
    • INTRARECTAL USE: Lubricate applicator well with Lonazem ointment, then gently insert applicator into the rectum.
    • Children under 12 years of age: consult a doctor

  • Inactive Ingredients

    butyrospermum parkii (shea) butter, cetearyl alcohol, juniper berry volatile oil, origanum vulgare leaf extract, rosmarinus officinalis leaf extract, thymus vulgaris leaf extract, zea mays (corn) oil

  • Questions or comments?

    Contact us at lonazem.com or at Dorrington LLC, 7 Skyline Dr., Suite 350, Hawthorne, NY 10532

  • Product label

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  • INGREDIENTS AND APPEARANCE
    LONAZEM 
    menthol,petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM80 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    OREGANO (UNII: 0E5AT8T16U)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    ROSEMARY (UNII: IJ67X351P9)  
    CORN OIL (UNII: 8470G57WFM)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1200-110 in 1 CARTON03/01/2024
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01503/01/2024
    Labeler - PEER PHARM LTD. (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEER PHARM LTD.514678390manufacture(69435-1200)