FDA Label for Gel Cooling Pain Relief

View Indications, Usage & Precautions

Gel Cooling Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Consumer Product Partners, Llc. 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 Ingrident



Menthol 4%


Purpose



External analgesic


Uses



for temporary relief from minor aches and pains of muscles & joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only

Flammable, keep away from fire or flame.


When Using This Product



  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use And Ask A Doctor If



condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days


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: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other Information



store in a cool dry place with lid closed tightly


Inactive Ingredients



Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5


Disclaimer



This product is not manufactured or distributed by Biofreeze Performance Health, distribtor of BioFreeze Cool the Pain Roll-On Fast Acting Menthol Pain Relief.


Adverse Reactions Section



Distributed by: Vi-Jon, LLC

St. Louis MO 63114


Principal Display Panel



swan ®

ROLL-ON COOLING PAIN RELIEF

PAIN RELIEVING GEL

soothing menthol

  • For arthritis, sore muscles, joints and back pain
  • Diminshing scent
  • Compare to Biofreeze ®Cool the Pain Roll-On Fast Acting Menthol Pain Relief*

    2.5 FL OZ (74 mL)


* Please review the disclaimer below.