FDA Label for Zims Max Freeze
View Indications, Usage & Precautions
Zims Max Freeze 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.
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Drug Facts
Distributed by:
KOBAYASHI Consumer Products, LLC
P.O. Box 1191, Dalton, GA 30722
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Lidocaine HCl 4% | Topical anesthetic |
| Menthol 1% | Topical analgesic |
Uses
For the temporary relief of pain
Warnings
For external use only
Do Not Use
- more than 1 patch on your body at a time
- if you are allergic to any ingredients in this product
- on open wounds, damaged or irritated skin
- with a heating pad or TENS device or other topical analgesics
- 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
- may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
- if severe burning sensation occurs, discontinue use immediately
- may leave a blue stain on skin, which is safe and can be removed by washing with soap and water
- avoid contact with silk
- dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the active ingredients that can produce serious adverse effects if a child or pet chews or ingests this patch
Stop Use And Ask A Doctor If
- burning sensation is painful and persistent
- condition worsens
- rash, itching, redness, swelling, blistering 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 and pets. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over:
- clean and dry affected area
- remove film from patch and apply to the skin (see illustration)
- apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- consult a doctor
Children under 12 years of age:
Other Information
- store in a cool place away from direct sunlight
Inactive Ingredients
FD&C Blue No. 1, Glycerin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Polyvinyl Alcohol, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Oleate, Sorbitol, Tartaric Acid, Vanillyl Butyl Ether, Water
Principal Display Panel - 5 Patch Pouch Box
ZIM'S™
MAX-
FREEZE
LIDOCAINE 4%
& MENTHOL
HYDRO COOLING
PAIN RELIEF PATCH
DEEP
PENETRATING
- LIDOCAINE
- MENTHOL
- EXTRA COOLING
Fast Acting & Long Lasting
Hydrated Gel Patch
5 PATCHES
3 15/16" X 5 1/2" (10 cm X 14 cm)
Individually Packaged
BACK, Hip, Neck, Shoulder, Knee
* Please review the disclaimer below.