ZIMS MAX FREEZE- menthol gel
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 3.7%

Purpose

Topical Analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only

Do not use

if you are allergic to any ingredient in Zim's Max-Freeze
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

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 heal

Stop use and ask a doctor if

condition worsens or
symptoms persist for more than 7 days or dear 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, got medical help or contact a poison control center right away.

Directions

Adults and children 12 years and older

Apply and gently massage painful joint and/or muscles.
Repeat as needed no more than 4 times a day.
Wash hands after each use with cold water.

Other information

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

Inactive ingredients

†Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, †Ilex Paraguarionsis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

†Symbol before the ingredient indicates certified organic.

Principal Display Panel - 4 oz Tube Label

ZIMS®

MAX FREEZE

MUSCLE & JOINT*

Greaseless, vanishing scent formula.
Organic ilex & aloe, arnica,
vitamin e and tea tree oil.
Paraben & sulfate free.

Nature Science

Net Wt 4 oz. (113.4g)

Principal Display Panel - 4 oz Tube Label

Principal Display Panel - 3 oz Bottle Label

ZIMS®

MAX FREEZE

MUSCLE & JOINT*

Greaseless, vanishing scent
formula. Organic ilex & aloe,
arnica, vitamin e and tea tree oil.

Nature Science

89 mL (3 fl oz)

Principal Display Panel - 3 oz Bottle Label

PRINCIPAL DISPLAY PANEL - 5 g SAMPLE Pouch Label

ZIM'S®
MAX-
FREEZE

PAIN RELIEF

Greaseless, vanishing scent formula.
Organic ilex & aloe, arnica,
vitamin e and tea tree oil.
Paraben & sulfate free.

Nature Science

ZimsUSA.com
5g SAMPLE

PRINCIPAL DISPLAY PANEL - 5 g SAMPLE Pouch Label

ZIMS MAX FREEZE
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	37 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66902-014-04	113.4 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2014	12/31/2021
2	NDC:66902-014-03	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2014	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/01/2014	12/31/2021

ZIMS MAX FREEZE
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	37 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66902-400-05	1 in 1 BOTTLE, WITH APPLICATOR	03/29/2018	12/31/2021
1		5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/01/2014	12/31/2021

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Name	Address	ID/FEI	Business Operations
Establishment
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-014, 66902-400)

Revised: 1/2018

Document Id: 1b28eb92-5661-4cdd-8e58-dffc8802b4ba

Set id: c85b499a-bb7a-4fc1-9401-4966d7e2a07e

Version: 6

Effective Time: 20180101

NATURAL ESSENTIALS, INC.