ZIMS MAX FREEZE- menthol, lidocaine and menthyl salicylate patch 
NATURAL ESSENTIALS, INC.

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.

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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:

WARNINGS:

Use only as directed.

  • 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

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 - Medium Pouch Label

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 - Large Pouch Label

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

Principal Display Panel - Extra Large Pouch Label
ZIMS MAX FREEZE 
menthol, lidocaine and menthyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-113
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-0.4 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA (UNII: O80TY208ZW)  
BORNEOL (UNII: M89NIB437X)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-113-066 in 1 CANISTER
11 in 1 POUCH
11 in 1 PATCH; Type 0: Not a Combination Product
2NDC:66902-113-044 in 1 CANISTER
21 in 1 POUCH
21 in 1 PATCH; Type 0: Not a Combination Product
3NDC:66902-113-033 in 1 CANISTER
31 in 1 POUCH
31 in 1 PATCH; Type 0: Not a Combination Product
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/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-113)

Revised: 2/2016
Document Id: 21134cd7-2481-40d7-af0b-6844a7089fb3
Set id: ce4a477a-f947-422e-85ac-72b16f7b92f2
Version: 1
Effective Time: 20160210
 
NATURAL ESSENTIALS, INC.