Zims Max Freeze (Menthol, Unspecified Form) Spray [Kobayashi Healthcare International, Inc.] -

ZIMS MAX FREEZE (MENTHOL, UNSPECIFIED FORM) SPRAY [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]
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NDC	54273-004-01, 54273-004-02
Set ID	a30fd8fa-30a5-4cc3-a25f-acded206152e
Category	HUMAN OTC DRUG LABEL
Packager	KOBAYASHI Healthcare International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART348

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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

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 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	09/01/2017

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)

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Medic

ZIMS MAX FREEZE (MENTHOL, UNSPECIFIED FORM) SPRAY [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]

Flammable

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