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 Natural Essentials, 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.

Active Ingredients:



NATURAL Menthol USP 5%

Lidocaine 4%

Methyl Salicylate 0.04%


Purpose:



Topical Analgesic

Topical Analgesic

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:



Use only as directed.

  • For external use only

Otc - Do Not Use



  • Do Not use if you are allergic to any ingredient in Zim's Max-Freeze Patch
  • Do Not use if you have had allergic reaction to aspirin or other salicylate products
  • Use caution with blood thinning medications, NSAIDS, steroids or nonsteroidal anti-inflammatory drugs
  • If conditions worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician
  • Avoid contact with eyes or mucous membranes

Otc - Pregnancy Or Breast Feeding



  • PREGNANCY - Breast Feeding Warning: If pregnant or breastfeeding, ask a physician before use.
  • Do not use with other topical products.
  • Do not use with heating devices.
  • Do not use on open wounds, damaged or irritated skin
  • Keep away from excessive heat.

Otc - Keep Out Of Reach Of Children



  • Keep this and all medicine out of reach of children.
  • Accidental ingestion: Seek professional help and contact Poison Control immediately
  • Under age 12 Consult a physician before use.

Directions:



Adults/children 12 years and older

  • Strip off the polyethylene film and place adhesive pad over affected area.
  • Change pad 1 or 2 times a day.
  • Wash Hands after applying patch.

Other:



Store at room temperature - do not exceed 86° Fahrenheit


Inactive Ingredients:



†Aloe Barbadensis Leaf Extract, Aluminum Hydroxide, Alcohol, Arnica Extract, Borneol, Camphor, EDTA-2Na, Glycerin, NP-700, PVPP, Tartaric Acid, Titanium Dioxide, Water.

Distributed by: Perfecta Products, Inc., North Lima, OH 44452

(800) 319-2225-www.ZimsUSA.com

©2015 Perfecta Products, Inc.®


Principal Display Panel - Medium Pouch Label



ZIM's

MAX

FREEZE

PATCHES

MUSCLE & JOINT*

Description: Zim's Max-Freeze Patch

Size: Medium

Lot#: 123456

Expiration Date - 1/1/19


Principal Display Panel - Large Pouch Label



ZIM's

MAX

FREEZE

PATCHES

MUSCLE & JOINT*

Description: Zim's Max-Freeze Patch

Size: Large

Lot#: 123456

Expiration Date - 12/25/18


Principal Display Panel - Extra Large Pouch Label



ZIM's

MAX

FREEZE

PATCHES

MUSCLE & JOINT*

Description: Zim's Max-Freeze Patch

Size: Extra Large

Lot#: 123456

Expiration Date - 1/5/19


* Please review the disclaimer below.