FDA Label for Flex24 Pain Pen

View Indications, Usage & Precautions

Flex24 Pain 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, cramps, 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.


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 liniment to affected area

• Repeat as necessary but no more than 3 treatments per day

• Children under 12, consult a doctor before use.


Other Information



Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure


Inactive Ingredients



Aconitum Kusnezoffii Root, Angelica Dahurica Root, Angelica Sinesis Root, Asarum Heterotropoides var. 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, Rehmannia Glutinosa Root (Raw), Rhubarb, Safflower, Tangerine Peel, Turmeric, White Paeonia Lactiflora Root, Wintergreen Oil, Zanthoxylum Nitidum Root, Zeodary


Questions/Comments?



www.larasan.com/painpen


Flex24™ Pain Pen



Powerful Pain Relief

Distributed by: Larasan Pharmaceutical Corporation, 401 East Las Olas Blvd., Suite 1400, Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC 54641-003-02

Made in Chinda

Lot No.:

Expiry Date:

Larasan

Nature Bioscience Health

© Larasan Pharmaceutical 2014

Powerful Pain Relief

Aches Pains Bruises Sprains

Topical Analgesic

0.61 fl. oz. (18 mL)


* Please review the disclaimer below.