Lmx5 Cream
FDA Label NDC 0496-0883

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ferndale Laboratories, Inc. for the product Lmx5 (NDC 0496-0883). 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 ingredient, purpose, uses, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

temporarily relieves pain and itching due to anorectal disorders

When Using This Product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor

Stop Use And Ask A Doctor If

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • When practical, clean area with mild soap and warm water and rinse thoroughly.  Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and Children 12 years and older:  Apply to the affected area up to 6 times a day.
  • Children under 12 years of age:  Consult a doctor.

Other Information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

benzyl alcohol, carbomer 940, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

Package Label

Manufactured for Ferndale Healthcare Inc.

Ferndale, MI 48220 U.S.A.

Toll free (888) 548-0900

www.ferndalehealthcare.com


L.M.X.5® is a registered trademark of Ferndale, IP Inc.

30 gram NDC 0496-0883-30

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