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ZIMS MAX FREEZE by NATURAL ESSENTIALS, INC.

Medically reviewed on February 12, 2018

Dosage form: patch
Ingredients: MENTHOL 50mg, LIDOCAINE 40mg, MENTHYL SALICYLATE, (+/-)- 0.4mg
Labeler: NATURAL ESSENTIALS, INC.
NDC Code: 66902-113

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

  • 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

  • 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.

  • 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

ZIMS MAX FREEZE 
menthol, lidocaine and menthyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-113
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg
LIDOCAINE (LIDOCAINE) LIDOCAINE40 mg
MENTHYL SALICYLATE, (+/-)- (SALICYLIC ACID) MENTHYL SALICYLATE, (+/-)-0.4 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
ALCOHOL 
ARNICA MONTANA 
BORNEOL 
CAMPHOR (SYNTHETIC) 
EDETATE DISODIUM 
GLYCERIN 
COPOVIDONE K25-31 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:66902-113-066 POUCH in 1 CANISTER
11 PATCH in 1 POUCH
11 PATCH in 1 PATCH
2NDC:66902-113-044 POUCH in 1 CANISTER
21 PATCH in 1 POUCH
21 PATCH in 1 PATCH
3NDC:66902-113-033 POUCH in 1 CANISTER
31 PATCH in 1 POUCH
31 PATCH in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2016
Labeler - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIOperations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-113)

 
NATURAL ESSENTIALS, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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