Active Ingredient
Camphor, 7.79%
Flex24 Pain Pen
FDA Label NDC 73218-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Flex24, Inc. for the product Flex24 Pain Pen (NDC 73218-003). 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, otc - 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults and children 2 years of age and older:
• Remove plastic top from device and put aside till after treatment
• Squeeze device if necessary and apply ointment to the affected area
• Repeat as necessary but no more than 3 treatments per day
Children under 2 years of age, consult a physician.
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
Other
FLEX24®
RECOVER NATURALLY
Dist: FLEX24, INC.
4020 Galt Ocean Mile, Ste. 1607
Ft. Lauderdale, FL 33308
Tel.: 844.4.FLEX24
Formulated in USA
Made in China
Package Label.Principal Display Panel
ROLL-ON PEN
PAIN RELIEF
WORKS FOR ARTHRITIS
• ALL NATURAL
• FAST ACTING
• LONG LASTING
Topical Analgesic
0.61 fl. oz. (18 mL)
• Plant based medicine for pain relief
• Fast acting and long lasting
• Works for: aches, pains, & strains
FLEX24®
RECOVER NATURALLY
20190828_73218_painpen (20190828 73218 Painpen)
* Please review the disclaimer below.
