FDA Label for Zims Max Freeze Leg Cramp

View Indications, Usage & Precautions

Zims Max Freeze Leg Cramp 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


Otc - Purpose



Active ingredientsPurpose  
Camphor 3.1%Topical analgesic
Menthol 5%Topical analgesic
Methyl Salicylate 11.5%Topical analgesic

Uses



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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
  • Cramps

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
  • after expiration date

When Using This Product



  • to avoid excess application, press applicator gently against skin
  • do not bandage tightly or cover with wrap or use heating pad or TENS device
  • do not use 1 hour prior to bathing or within 30 minutes after bathing
  • do not use other 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, burning sensation, swelling or blistering 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 you are pregnant or breastfeeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children and pets. If swallowed, get medical help, or contact a Poison Control Center immediately.


Directions



Adults and children 12 years of age and over:

  • apply to affected area not more than 4 times daily
  • Children under 12 years of age:

    • consult a doctor

Other Information



  • allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use
  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive Ingredients



Dimethyl Isosorbide, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Tocopheryl Acetate, Water, Zingiber Officinale (Ginger) Root Extract.


Principal Display Panel - 89 Ml Bottle Carton



ZIM'S™
MAX-
FREEZE

For Minor Pain Caused by
LEG CRAMPS

Relax & Relieve
Muscles

Fast Acting
Liquid

Easy to Use
Angled Bottle

Pain Relieving
Liquid
3 fl oz (89mL)

3 POWERFUL INGREDIENTS


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