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 Kroger. 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


Use



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


Adverse Reactions Section



Biofreeze is a registered trademark of Biofreeze Performance Health, Cuyahoga Falls, OH Biofreeze Performance Heath is not affilated with The Kroger Co. or this product.

DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 415202

QUALITY GUARANTEE

800-632-6900

www.kroger.com


Principal Display Panel



COMPARE TO the active igredient in BIOFREEZE PAIN RELIEF GET

Kroger

Cooling

Therapy

Relief

Pain Relieving Gel

Cold Pain Relief Therapy

Fast Acting Menthol Pain Relief

Provides Temporary Relief from

Sore Muscles, Joints, Sprains,

Strains & Bruises

3 FL OZ (89 mL)


* Please review the disclaimer below.