ZIMS MAX FREEZE- menthol, unspecified form spray

ZIMS MAX FREEZE by

Drug Labeling and Warnings

ZIMS MAX FREEZE by is a Otc medication manufactured, distributed, or labeled by KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC. 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
• Sprains

Warnings

For external use only

Flammable

Keep away from fire or flame and heated surfaces

Do not use

• if you are allergic to any ingredient in Zim's Max-Freeze
• on open wounds, damaged or irritated skin
• with a heating pad or TENS device
• near face
• after expiration date

When using this product

• do not bandage tightly
• do not use otherwise than as directed
• avoid contact with eyes or mucous membranes

Stop use and ask a doctor if

• condition worsens
• rash, itching, redness or excessive irritation of the skin develops
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

• CONTENTS UNDER PRESSURE. DO NOT PUNCTURE OR INCINERATE.
• DO NOT STORE ABOVE 120°F (48°C)

Directions

Adults and children 12 years of age and over:

• spray affected area not more than 4 times daily
• no need to rub
• wash hands after each use with cold water

Children under 12 years of age: consult a doctor

Other information

• store in a cool place away from direct sunlight
• store with cap closed tightly

Inactive ingredients

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

†Symbol before the ingredient indicates certified organic.

QUESTIONS

Consumer Comments Call: 800-319-2225

SPL UNCLASSIFIED SECTION

Distributed by:
KOBAYASHI Consumer Products, LLC
P.O. Box 1191, Dalton, GA 30722

PRINCIPAL DISPLAY PANEL - 118 mL Can Label

ZIM'S™
MAX-
FREEZE

ADVANCED FORMULA
- Muscle & Joint -
PAIN RELIEF

Greaseless, vanishing
scent with organic
ilex, aloe & arnica plus
vitamin e and tea tree oil.

Paraben & sulfate free.

Continuous
Multi-Way Spray

CONTINUOUS
COOLING SPRAY
with Menthol

Net Vol 4 fl oz (118mL)

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE 
menthol, unspecified form spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-004
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 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54273-004-01	109 g in 1 CAN; Type 0: Not a Combination Product	09/01/2017
2	NDC: 54273-004-02	131 g in 1 CAN; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	09/01/2017

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)