Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate Ointment
FDA Label NDC 42333-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Dr. Collado, S.a. for the product Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate (NDC 42333-000). 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, use, warnings, do not use, 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.

Active Ingredients

Menthol 4%Methyl Salicylate 10%

Purpose

External Analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only.

Do Not Use

  • on wounds or damaged skin

When Using This Product

  • avoid contact with eyes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

Directions

Audlts and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 yeas of age: Do not use, consult a doctor.

Other Information

  • Store in a clean dry place at temperatures less than 86°F (30°C)

Inactive Ingredients

Camphor, Carbomer, Cetrimonium Chloride, Cetyl Alcohol, Ethyl Alcohol, Eucalyptus Globulus Leaf Oil, FD&C Blue No.1, Purified Water, Triethanolamine.

Questions Or Comments?

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