Active Ingredients
Active ingredients Purpose
Natural Menthol USP 9%....................................................Topical Analgesic
Avedana Pain Relief
FDA Label NDC 43749-510
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Pain Relief (NDC 43749-510). 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, purpose, directions, warnings, flammable, ask a doctor before using if you, 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
Purpose
Active ingredients Purpose
Natural Menthol USP 9%....................................................Topical Analgesic
Directions
Directions: Spray to completely cover painful area. Get extra relief by using after warm shower or bath. Reapply as needed.
Directions: Spray to completely cover painful area. Get extra relief by using after warm shower or bath. Reapply as needed.
Warnings
For external use only.
Flammable
Keep away from excessive heat or open flames.
Ask A Doctor Before Using If You
Ask a doctor before using if you: have sensitive skin, are pregnant or are breast feeding.
When Using This Product:
When using this product:
-Avoid contact with eyes and mucous membranes.
-Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops.
Stop Use And Ask A Doctor If:
Stop use and ask a doctor if: condition worsens, symptoms persist more than 7 days, or clear up and reoccur.
Keep Out Of Reach Of Children:
Keep out of reach of children: If ingested, seek medical help and contact poison control center immediately.
Other Information
Store in a cool, dry place with spray cap screwed tightly.
Inactive Ingredients:
Inactive Ingredients: Arnica montana, Boswellia serrata Extract, Camphor USP, Coconut Oil, Eucalyptus globulus Leaf Oil, Ilex paraguariensis Extract, Isopropyl Alcohol USP, Lavender Oil, Methyl salicylate, Peppermint Oil, Propylene Glycol USP, and Purified Water
* Please review the disclaimer below.
