SPL v2
SPL
SPL Set ID 91f7a741-4178-4639-9cd5-746a4b9a21bf
Route
TOPICAL
Published
Effective Date 2024-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.1 g) Petrolatum (80 g)
Inactive Ingredients
Juniper Berry Oil Oregano Thymus Vulgaris Leaf Rosemary Corn Oil Shea Butter Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Menthol 0.1% Petrolatum 80%

Purpose

Menthol…….Antipruritic Petrolatum…..Protectant


Medication Information

Purpose

Menthol…….Antipruritic

Petrolatum…..Protectant

Description

Menthol 0.1% Petrolatum 80%

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

Product Label

Active Ingredients

Menthol 0.1%

Petrolatum 80%

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


Structured Label Content

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
Purpose

Menthol…….Antipruritic

Petrolatum…..Protectant

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

Product Label (Product label)

Active Ingredients

Menthol 0.1%

Petrolatum 80%

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? (Questions or comments?)

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


Advanced Ingredient Data


Raw Label Data

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