Active Ingredient:
Menthol 3.00%
Invigo Flex Pain Relief Gel
FDA Label NDC 35324-276
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wynnpharm Inc. for the product Invigo Flex Pain Relief Gel (NDC 35324-276). 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, uses:, warnings:, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains.
Warnings:
For external use only
Do Not Use
• on damaged or broken skin.
When Using This Product
• Avoid contact with the eyes. • Do not bandage tightly.
Stop Use And Ask A Doctor
• rash or irritation develops and lasts. • condition worsens, or if symptoms persist for more than 7 days or clears up and occur again within a few days.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions
• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: consult a doctor.
Other Information
• Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, GLycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hydroxyethyl Cellulose, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonulmethane (MSM), Phenoxyethanol, Propylene Glycol, Triethanolamine.
Questions?
1-800-214-9600
Package Labeling:
Label2 (Label2)
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