Bt Pain Relief Balm Ointment
FDA Label NDC 82198-0010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Big 5 Nutrition Llc for the product Bt Pain Relief Balm (NDC 82198-0010). 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, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

​Drug Facts

​Active Ingredients

Methyl Salicylate 20.7%
Menthol 15.6%
Camphor 3.1%

​Purpose

External Analgesic   

​Uses

For the temporary relief of minor aches and pains of muscles due to:

  • strains
  • bruises
  • sprains
  • simple backache
  • travel and motion sickness
  • itching from insect and mosquito bites
  • heat stroke and dizziness

​Warnings

For external use only.

Do not use

  • on wounds • irritated or damaged skin
  • sensitive skin • with a heating pad • if pregnant
  • with, or as the same time as, other external analgesic products
  • if allergic to aspirin or salicylates
  • if allergic to any ingredients of this product

    • When using this product

    • avoid contact with the eyes
    • do not bandage tightly
    • do not apply to wounds or damaged skin
    • do not use 1 hour before or after bathing

      • Stop use and ask a doctor if

      • condition worsens 
      • symptoms persist for more than 7 days 
      • symptoms clear up and occur again within a few days 
      • excessive irritation of the skin develops
      • redness is present • side effects occur.

        • If pregnant, ask a health professional before use.

Directions

  • ​Apply to the affected area. Rub well on affected area.
  • Repeat a few times daily.
  • ​​Children under 2 years of age: Do not use or consult a doctor

Other Information

  • Store unused products in the box
  • Store at room temperature, 20 to 25 ​o​C (68 to 77 ​o​F)​​​

Inactive Ingredients

Cinnamomum kanehirae Hayata Essential Oil, Eucalyptus oil, Lavender oil, Vaseline, White beeswax, FD&C Yellow No. 4

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