Ultra Strength Pain Relief Balm
FDA Label NDC 52486-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mccure Health Solutions Inc. for the product Ultra Strength Pain Relief Balm (NDC 52486-013). 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, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 11%

Menthol 11%

Purpose

Topical analgesic

Uses

For temporary relief minors aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

Warnings

For external use only

When Using This Product

  • Avoid contact with eyes and mocous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Stop Use And Ask A Doctor If

  • Condition worsens
  • Severe skin irritation occurs.
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later

If Pregnant Or Breast-Feeding,

ask a healthcare professional before use

Keep Out Of Reach Of Children.

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

Directions

  • Rub well on the affected area. Repeat 3 to 4 times daily

Other Information

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive Ingredients

CAJUPUT OIL, CLOVE OIL, DEMENTHOLIZED MINT OIL, PARAFFIN PETROLATUMA

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