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 16%


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 near sparks or while smoking
  • do not use in a small or confined space
  • avoid long term storage above 104° F (40° C)
  • do not puncture or incinerate. Contents under pressure.
  • do not expose to temperature exceeding 119° F (48° C)

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
  • near face
  • 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
  • avoid inhalation
  • menthol may cause a cold or burning sensation wherever it is applied, but is usually mild and gradually lessens over time
  • if severe burning sensation occurs, discontinue use immediately

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:

  • spray affected area not more than 4 times daily
  • no need to rub
  • 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 cap locked tightly

Inactive Ingredients



†Aloe Barbadensis Leaf Extract, Arnica Extract, Glycerin, SD Alcohol 40-B, Tea Tree Oil, Vanillyl Butyl Ether, Water.

†Symbol before the ingredient indicates certified organic


Otc - Questions



Consumer Comments Call:
1-800-432-8629


Principal Display Panel - 96 G Can Label



IMPROVED

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING* -
PAIN RELIEF

  • -FAST ACTING
  • -LONG LASTING
  • -VANISHING SCENT
  • CONTINUOUS
    COOLING SPRAY
    with 16% Menthol

    Net Wt 3.4oz (96g)
    *compared to original

    Continuous
    Multi-Way Spray


* Please review the disclaimer below.