Menticam Gel
FDA Label NDC 59088-203

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Menticam (NDC 59088-203). 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 other, active ingredients, purpose, uses, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Active Ingredients

Camphor 4%
Menthol 10%
Methyl salicylate 30%

Purpose

Camphor - Topical analgesic
Menthol - Topical analgesic
Methyl Salicylate - Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple bachache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings:

For external use only

Do Not Use

  • on wounds 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 affected area

When Using This Product

  • use only as directed 
  • avoid contact with the eyes or mucous membranes 
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or 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 right away.

Directions

  • do not use otherwise than directed
  • 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: consult a doctor

Other Information

Store at controlled room temperature 20°-25°C (68°-77°C).

Avoid excessive heat. Do not use if package is damaged. Keep out of reach of children.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Purified Water), Benzyl Alcohol, Carbomer, Polysorbate 80, Triethanolamine

How Supplied

Menticam™ Gel is an anti-inflammatory anesthetic in a 3.5 oz/ 100 g tube.
NDC 59088-203-07

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