ZIMS MAX FREEZE CONTINUOUS- menthol spray

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 INGREDIENT:

NATURAL Menthol USP 3.7%

PURPOSE:

Topical Analgesic

*USES:

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

WARNINGS:

Use only as directed.

• For external use only
• If condition worsens or if 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 breast feeding, 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 or open flame.

• Keep this and all medicine out of reach of children.
• Accidental ingestion: Seek professional help and contact Poison Control immediately.
• CONTENTS UNDER PREASSURE, DO NOT PUNCTURE OR INCINERATE.
• DO NOT STORE ABOVE 120°F (48°C)

DIRECTIONS:

Adults and children 12 years and older

• Spray evenly over painful joints and/or muscles.
• No need to rub. Leave sprayed area to dry.
• Repeat as necessary, no more than 4 times a day.
• Do not spray near face. Spray in hands to apply near face.
• If using hands to apply, wash with cold water when finished.

OTHER:

Store in cool, dry area - close cap tight

INACTIVE INGREDIENTS:

†Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, †llex Paraguariensis Leaf Extract, SDA-39C, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Water.

Principal Display Panel - Zim's Max Freeze Continuous Spray Label

ZIM'S®

MAX

FREEZE

COUNTINUOS SPRAY

MUSCLE & JOINT*

Greaseless, vanishing scent formula.

Organic ilex & aloe, arnica, vitamin e
and tea tree oil.

Nature Science

118.29 mL (4 fl oz)

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE   CONTINUOUS
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	37 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
Tea Tree Oil (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-416-04	1 g in 1 CAN; Type 0: Not a Combination Product	01/01/2016

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(66902-416)