Thera Plus Cold Therapy Pain Relieving Menthol Gel
Product Images NDC 80684-101

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This gallery contains 2 technical images submitted to the FDA as part of the official labeling for Thera Plus Cold Therapy Pain Relieving Menthol (NDC 80684-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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FDA Label Image

Inner Package (Inner Package)

Inner Package (Inner Package)
Cold Therapy Pain Relieving Gel is a fast-acting cooling muscle relief gel that can be used for arthritis, backache, joint pain, and muscle pain. It comes with a convenient no mess roll-on applicator. The active ingredient in this gel is Menthol 4%. It temporarily relieves minor aches and pains of muscles and joints associated with backaches, arthritis, strains, and bruises. There are some warnings to keep in mind, such as keeping the gel away from excessive heat or open flames as it is flammable. Avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin. It should not be tightly bandaged or used with a heating pad or device. If any pain, swelling, or blistering of the skin occurs, it is advised to stop using the product and consult a doctor. The directions for use state that adults and children 2 years of age and older can apply a thin film over the affected area, not more than 3 to 4 times daily. If using on children under 2 years of age, it is recommended to consult a physician. Hands should be washed after use with cool water. The gel should be stored in a cool dry place away from direct sunlight, between 20°C to 25°C (68°F to 77°F). The gel contains aloe barbadensis leaf juice, arctium lappa extract, amica montana flower extract, bluef, boswellia serrata extract, calendula officinalis flower extract, camella sinensis leaf extract, camphor, carbomer, glycerin, lex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl salicylate, octyl salicylate, tocopheryl acetate, hamamelis virginiana extract, yellow 5, and water as inactive ingredients. For any questions or comments, the company's contact information is provided. Please note that TheraPlus® is not manufactured or distributed by Biofreeze IP Holdings, LLC, although it shares some similarities to BioFreeze®, a registered trademark of Biofreeze IP Holdings, LLC. The gel is manufactured for Fourstar Group USA, Inc.*
FDA Label Image

Outer Package (Outer Package)

Outer Package (Outer Package)
Plus Cold Therapy Pain Relieving Gel is a topical gel that provides temporary relief for minor muscle aches and pains. Its active ingredient is menthol, which helps to alleviate pain. This gel is suitable for adults and children aged 2 and older. It should be applied to the affected area no more than 3 to 4 times a day. The gel should not be used on wounds, damaged or irritated skin, or in conjunction with heating pads. If symptoms persist for more than 7 days, worsen, or occur again within a few days, it is recommended to consult a doctor. Pregnant or breastfeeding individuals should consult a healthcare professional before using this gel. It is important to keep this gel out of reach of children and to seek medical help if swallowed. The gel should be stored in a cool, dry place away from direct sunlight.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.