Flex24 Performance
FDA Label NDC 54641-006

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 54641-006). 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

Active Ingredients

Camphor, 3%

Menthol, 2.52%

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

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 the 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

Adults and children over the age of 12:

• Remove plastic backing from patch and discard

• Apply one patch to affected area

•Patch should be comfortable but not tight

• Repeat if necessary but no more than 3 per day

Children under 12, consult a doctor before use.

Inactive Ingredients

Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide

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.larasan.com/performancepatch

Other

Flex24™ Performance Patch

Quick Relief for the Pain Of

Arthritis • Strains • Cramps • Bruises

Distributed By

Distributed by:

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC 54641-006-01

Made in China

Patch size 8 cm x 13 cm

Package Label.Principal Display Panel

Flex24™ Performance Patch

24/7 Topical Analgesic

Improve Performance

Reduce Pain

7 Large Patches

Lasts Up to 24 Hours

* Please review the disclaimer below.