Biosavia External Analgesic Pain Relief Gel
FDA Label NDC 84680-529

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biosavia Usa, Llc for the product Biosavia External Analgesic Pain Relief (NDC 84680-529). 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, do not, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Capsaicin 0.025 %

Purpose

Topical Analgesic

Uses

Temporaryly relieves minor aches and pains of muscles and joints associated with

  • strains
  • bruises
  • sprains
  • arthritis
  • simple neck or back ache

Warnings

For external use only

Do Not

  • use on wounds or damaged skin
  • use if you are allergic to any ingredients in this product

When Using This Product

  • Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • symptoms persist or get worse after than 7days
  • swallowed

If Pregnant Or Breast-Feeding,

ask a health professional before use

Keep Out Reach Of Children

Directions

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

  • Massage evenly where needed until the gel is fully absorbed 
  • Massage your feet for a better sleep
  • For a craneal massage, use on your head from your neck to your temples pressing all over your scalp
  • massage on afected area for physical fatigue, swollen feet and legs

Other Information

  • Store between 20-25C (68-77 F)
  • store in a cool dry place away from direct sun light

Other Ingredients

Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, DMDM Hydantoin, Glycerin, Isopropyl Myristate, Mentha Piperita (Peppermint) Oil, Mineral Oil, Panax Ginseng Root Extract, PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, Red 40 (CI 16035), Sodium Hydroxide, Tetrasodium EDTA, Water (Aqua)

Questions?

(954) 588-9852

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