Active Ingredient
Camphor, 7.79%
Flex24 Pain Pen
FDA Label NDC 54641-003
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 Pain Pen (NDC 54641-003). 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, keep out of reach of children, 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, 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.
