Lonazem Ointment
FDA Label NDC 69435-1200

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharm Ltd. for the product Lonazem (NDC 69435-1200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, inactive ingredients, questions or comments?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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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