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  5. Label Information: Flex24 Performance Pen

FDA Label for Flex24 Performance Pen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT
    6. STOP USE AND ASK A DOCTOR
    7. CAUTION
    8. PREGNANT OR BREAST FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. OTHER INFORMATION
    13. QUESTIONS/COMMENTS?
    14. DISTRIBUTED BY:
    15. FLEX24™ PERFORMANCE PEN

Flex24 Performance Pen Product Label

The following document was submitted to the FDA by the labeler of this product Larasan Pharmaceutical Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.