ZIMS MAX FREEZE- menthol and lidocaine 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Lidocaine 4%

Menthol USP 1%

Purpose

Topical Analgesic

Topical Analgesic

Use

• For the temporary relief of pain.

Warnings

For external use only

Do not use

• if you are allergic to any ingredient in Zim's Max-Freeze Patches
• if you have had an allergic reaction to aspirin or other salicylate products
• on open wounds, damaged or irritated skin
• in large quantities, particularly on raw surfaces or blistered areas.

Ask a doctor or pharmacist before use if you are

• using blood thinning medications, steroids or non-steroidal anti-inflammatory drugs (NSAIDS)

When using this product

• a do not use other topical products
• do not use with heating devices
• avoid contact with eyes or mucous membranes
• do not bandage tightly
• keep away from excessive heat

Stop use and ask a doctor if

• a condition worsens or
• symptoms persist for more than 7 days or
• clear up and occur again within a few days.

If pregnant or breast feeding ask a physician before use.

Keep out of reach of children. If put in the mouth get medical help or contact a poison control center right away.

Directions

Adults/children 12 years and older

• Strip off the polyethylene film and place adhesive patch over affected area
• Change patch 1 or 2 rimes per day
• Wash hands after applying patch
• Under age 12, consult a physician before use

Other information

Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.

Inactive ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Aluminum Hydroxide, Amica Extract, Bomeol, Camphor, EDTA-2Na, Glycerin, Methyl Salicylate, NP-700, PVPP, Tartaric Acid, Titanium Dioxide, Water.

Distributed by Perfects Products. Inc., North Lima. Ohio 44452

(800) 319-2225 www.ZimsUSA.com

©2016 Perfects Products, Inc.® Made in China

Principal Display Panel - Canister Label

ZIM'S®
MAX-
FREEZE
PATCHES

PAIN RELIEF

LIDOCAINE & MENTHOL

Targeted pain relief
in an individually wrapped,
easy to apply patch.

M

6 PATCHES

3" X 5" (7.6 x 12.7 cm)

Nature Science

Principal Display Panel - Patch Label

ZIM'S®
MAX
FREEZE
PATCHES

MUSCLE & JOINT®

Description: Zim's Max-Freeze Patch

Size: Medium

Lot#: 160301

Expiration Date: 3/5/19

Principal Display Panel - Canister Label

ZIM'S®
MAX-
FREEZE
PATCHES

PAIN RELIEF

LIDOCAINE & MENTHOL

Targeted pain relief
in an individually wrapped,
easy to apply patch.

L

4 PATCHES

4" X 5.5" (10.2 x 14 cm)

Nature Science

Principal Display Panel - Patch Label

ZIM'S®
MAX
FREEZE
PATCHES

MUSCLE & JOINT®

Description: Zim's Max-Freeze Patch

Size: Large

Lot#: 160305

Expiration Date: 3/15/19

Principal Display Panel - Canister Label

ZIM'S®
MAX-
FREEZE
PATCHES

PAIN RELIEF

LIDOCAINE & MENTHOL

Targeted pain relief
in an individually wrapped,
easy to apply patch.

XL

3 PATCHES

4" X 8" (10.2 x 20.3 cm)

Nature Science

Principal Display Panel - Patch Label

ZIM'S®
MAX
FREEZE
PATCHES

MUSCLE & JOINT®

Description: Zim's Max-Freeze Patch

Size: Extra Large

Lot#: 160310

Expiration Date: 3/25/19

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE 
menthol and lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-213
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 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)
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-213-06	6 in 1 CANISTER
1		1 in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 66902-213-04	4 in 1 CANISTER
2		1 in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 66902-213-03	3 in 1 CANISTER
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(66902-213) , REPACK(66902-213)