ZIMS MAX FREEZE- menthol gel

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

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 - 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 - 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

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE 
menthol gel

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

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (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)

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

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

ZIMS MAX FREEZE 
menthol gel

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

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-400-05	1 in 1 BOTTLE, WITH APPLICATOR	03/29/2018
1		5 mL in 1 PACKET; 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	01/01/2014

Labeler - NATURAL ESSENTIALS, INC. (947484713)

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