Bio 2 Brazilian Heat
FDA Label NDC 24488-036

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bio 2 for the product Bio 2 Brazilian Heat (NDC 24488-036). 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 ingredient, purpose, use, warnings, stop use and ask a physician if, keep out of reach of children, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active Ingredient
Menthol 7.0%


Purpose

PurposeExternal analgesi

Use

  • For the temporary relief of pain and soreness.
  • May help distract from pain.
  • May provide a cooling sensation.

Warnings

Only for external use.

Flammable. Keep away from heat
or flame.

  • Do not apply to irritated skin or if
    excessive irritation develops
  • Avoid getting into the eyes or
    mucos membranes.

Stop Use And Ask A Physician If

Stop use and ask a physiciansymptoms persist.

Keep Out Of Reach Of Children

If swallowed, seek medical advice
or contact a Poison Control Center
immediately.

Directions

Spray a light mist over the affected
area up to 6 times daily. Allow to
air dry.


Inactive Ingredient

Alcohol, Dimethyl Sulfone (MSM),
Eucalyptus Oil, Gelidiella acerosa,
Hydrogen Peroxide and Chlorine
Dioxide, Hypnea musciformis,
Magnesium, Peppermint Oil,
Sargassum filipendula,
Sodium, Sorbitol, Water, Zinc

Questions:

Paso Robles, CA 93446 USA
805.238.0300
www.bio2USA.com
Made in the U.S.A.

Package Label.Principal Display Panel

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Bio 2 Brazilian Heat (Brazillabelv2)

Bio 2 Brazilian Heat (Brazillabelv2)

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