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  5. Label Information: Bt Pain Relief Balm

FDA Label for Bt Pain Relief Balm

View Indications, Usage & Precautions

Table of Contents

    1. ​DRUG FACTS
    2. ​ACTIVE INGREDIENTS
    3. ​PURPOSE
    4. ​USES
    5. ​WARNINGS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?

Bt Pain Relief Balm Product Label

The following document was submitted to the FDA by the labeler of this product Big 5 Nutrition Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

​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


Questions Or Comments?



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