Flex24 Performance Pen
FDA Label NDC 54641-004

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 Pen (NDC 54641-004). 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, stop use and ask a doctor, caution, pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Camphor, 7.79%

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

Pregnant Or Breast Feeding

ask healthcare professional about use

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over the age of 12:

  • Remove plastic top from device and put aside till after treatment
  • Apply ointment to affected area
  • Repeat if necessary but no more than 3 treatments a day.

    • Children under 12, consult a doctor before use.

Inactive Ingredients

Aconitum kusnezoffii root, Angelica dahurica root, Angelica sinesis root, Asarum heterotropoides var. mandshuricum root, Drynaria fortunei root, Eleutherococcus nodiflorus root bark, Ethyl alcohol, Eucalyptus oil, Frosythia suspensa fruit, Frankincense, Gardenia jasminoides fruit, Lavender oil, Lemon, Myrrh, Paeonia suffruticosa root bark, Peppermint oil, Pinellia ternata root, Red paeonia lactiflora root, Rhemannia glutinosa root (raw), Rhubarb, Safflower, Tangerine peel, Turmeric, White paeonia lactiflora root, Wintergreen oil, Zanthoxylum nitidum root, Zeodary

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/performancepen

Distributed By:

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC 54641-004-02

Made in China

Flex24™ Performance Pen

Topical Analgesic

Aches Pains Bruises Sprains

0.34 fl. oz. (10 mL)

* Please review the disclaimer below.