Lurosil
FDA Label NDC 58697-539

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pacific Health Collabroative for the product Lurosil (NDC 58697-539). 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, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 2.5%

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do Not Use

  • on wound s or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask A Doctor Before Use If You Have

redness over the affected area.

When Using This Product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep Out Of Reach Of Children

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

Directions

  • adults and children 12 years of age and older:  apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:  ask a doctor

Other Information

  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

Package Label

Image Of Carton Label (Musclejoint3.ph)

Image Of Carton Label (Musclejoint3.ph)

Purpose

Topical analgesic

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