Active Ingredients
Camphor, 3%
Menthol, 2.52%
Flex24 Performance
FDA Label NDC 54641-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Larasan Pharmaceutical Corporation for the product Flex24 Performance (NDC 54641-007). 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, uses, warnings, do not, stop use and ask a doctor, caution, pregnancy or breast feeding, 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 temporary relief of minor aches and pains of muscle and joints associated with simple arthritis, strains, bruises, and sprains
Warnings
For external use only.
Do Not
■ Apply to open wounds, or damaged, broken, or irritated skin
■ Bandage tightly
Stop Use And Ask A Doctor
if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days
Caution
■ Discontinue use if excessive irritation of the skin develops
■ Avoid contact with eyes and mucous membranes
■ Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately
Pregnancy Or Breast Feeding
ask healthcare professional about use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact the Poison Control Center right away.
Directions
■ Peel desired length of tape and cut with serrated edge.
■ Discard plastic backing from tape ■ Repeat as necessary, but no more than 3 per day
■ Apply tape to affected area. ■ Tape should be comfortably tight
■ Children under 12, consult a doctor before use
Inactive Ingredients
Angelica Dahurica, Cape Jasmine Fruit, Chinese Angelica, Cotton, Eucalyptus Oil, Ethyl Alcohol, Forsythia Seed Pod,
Fortune’s Drynaria Rhizome, Frankincense, Kusnezoff Monkshood root, Lavender Oil, Manchurian Wild Ginger, Myrrh,
Paper roll, Peppermint Oil, Pinellia Tuber, Red Peony Root, Rehmannia Root (raw), Rhubarb, Safflower, Slenderstyle
Acanthopanax Bark, Tangerine Peel, Tree Peony Bark, Turmeric, Weeping Wintergreen Oil, White Peony Root,
Zanthoxylum Nitidum, Zedoary.
Other Information
Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure.
Questions/Comments?
www.Flex24.com/performancetape
Other
Larasan Pharmaceutical Corp.
1287 E. Newport Center Drive, Suite 206
Deerfield Beach, FL 33442
Package Label.Principal Display Panel
20170117flex24perftape (20170117flex24perftape)
20170117Flex24PerfTape.jpg
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