Pain Relieving Balm
FDA Label NDC 51367-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by International Nature Nutraceuticals, Inc. for the product Pain Relieving Balm (NDC 51367-010). 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, uses, warnings, do not use, when using this product, stop using and consult with physician if, safety, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol- 12%

Camphor- 10%

Methyl Salicylate- 23%

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • sprains
  • bruises
  • strains

Warnings

For External Use Only

Do Not Use

Do not use

  • on wounds or damaged skin
  • if allergic to salicylates

When Using This Product

Avoid contact with the eyes, mouth, or mucous membranes

Do not bandage tightly

Stop Using And Consult With Physician If

Condition worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

Safety

Pregnant or lactating women consult a doctor before use

In case of accidental ingestion contact a doctor or Poision control center immediately

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Do not use, consult a doctor

Other Information

Keep tightly closed

Store in a cool and dry place

Do not use if seal is broken

Inactive Ingredients

Bees wax, Peppermint oil, Eucalyptus oil, Nutmeg oil

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