Nova Natura Topical Analgesic Patch
FDA Label NDC 84046-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Seyitler Kimya Sanayi Anonim Sirketi for the product Nova Natura Topical Analgesic (NDC 84046-001). 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 drug facts, active ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children to avoid accidental poisoning., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Camphor 3.3%

Capsicum oleoresin 0.045% as capsaicin

Methyl salicylate 10%

Purpose

Topical Analgesic

Use

  • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

When Using This Product

  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use otherwise than as directed

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
  • excessive irritation of the skin develops

Keep Out Of Reach Of Children To Avoid Accidental Poisoning.

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

Directions

  • Adults and children 3 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Consult a doctor.

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

Butylated hydroxytoluene, lanolin, paraffinum liquidium, zinc oxide.

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