FDA Label for Zims Max Freeze Pro Formula

View Indications, Usage & Precautions

Zims Max Freeze Pro Formula Product Label

The following document was submitted to the FDA by the labeler of this product Kobayashi Healthcare International, Inc.. 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.

Other



Drug Facts

Distributed by:
KOBAYASHI Consumer Products, LLC
P.O. Box 1191, Dalton, GA 30722


Active Ingredient



Menthol 7%


Purpose



Topical Analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings



For external use only


Flammable



Keep away from fire or flame and heated surfaces


Do Not Use



  • if you are allergic to any ingredient in this product
  • on open wounds, damaged or irritated skin
  • with a heating pad or TENS device
  • after expiration date

When Using This Product



  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes

Stop Use And Ask A Doctor If



  • condition worsens
  • rash, itching, redness or excessive irritation of the skin develops
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, ask a health professional before use.


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 12 years of age and over:

  • apply to affected area not more than 4 times daily
  • massage painful area until absorbed into skin
  • wash hands after each use with cold water
  • Children under 12 years of age: consult a doctor


Other Information



  • store in a cool place away from direct sunlight
  • store with lid closed tightly

Inactive Ingredients



†Aloe Barbadensis Leaf Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, †Arnica Extract, Hydroxypropylcellulose, Isopropyl Alcohol, Propylene Glycol, Tea Tree Oil, Vanillyl Butyl Ether, Water.

†Symbol before the ingredient indicates certified organic.


Otc - Questions



Consumer Comments Call: 800-319-2225


Principal Display Panel - 113 G Tube Label



IMPROVED

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING*-
PAIN RELIEF

- FAST ACTING
- LONG LASTING
- VANISHING SCENT

COLD THERAPY
COOLING GEL
with 7% Menthol

Net Wt 4oz. (113g)

*compared to original


* Please review the disclaimer below.