ZIMS MAX FREEZE- menthol, lidocaine and menthyl salicylate patch

ZIMS MAX FREEZE by

Drug Labeling and Warnings

ZIMS MAX FREEZE by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE 
menthol, lidocaine and menthyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-113
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MENTHYL SALICYLATE, (+/-)-	0.4 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-113-06	6 in 1 CANISTER
1		1 in 1 POUCH
1		1 in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 66902-113-04	4 in 1 CANISTER
2		1 in 1 POUCH
2		1 in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 66902-113-03	3 in 1 CANISTER
3		1 in 1 POUCH
3		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2016

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-113)