ZIMS MAX FREEZE PRO FORMULA- menthol 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 16%

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

Rare cases of burns have been reported with products of this type

Flammable

• keep away from fire or flame and heated surfaces
• do not use near sparks or while smoking
• do not use in a small or confined space
• avoid long term storage above 104° F (40° C)
• do not puncture or incinerate. Contents under pressure.
• do not expose to temperature exceeding 119° F (48° C)

Do not use

• if you are allergic to any ingredient in this product
• on open wounds, damaged or irritated skin
• with a heating pad or TENS device
• near face
• after expiration date

When using this product

• may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
• do not bandage tightly
• do not use otherwise than as directed
• avoid contact with eyes or mucous membranes
• avoid inhalation

Stop use and ask a doctor if

• burning sensation is painful and persistent
• 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.

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 locked tightly

Inactive ingredients

1Aloe Barbadensis Leaf Extract, Arnica Extract, Glycerin, SD Alcohol 40-B, Tea Tree Oil, Vanillyl Butyl Ether, Water.

1 Symbol before the ingredient indicates certified organic.

QUESTIONS

Consumer Comments Call:
1-800-432-8629

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 96 g Can Label

EXTRA STRENGTH

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING* -
PAIN RELIEF

• - FAST ACTING
• - LONG LASTING
• - VANISHING SCENT

CONTINUOUS
COOLING SPRAY
with 16% Menthol

Net Wt 3.4oz (96g)
*compared to original

Continuous
Multi-Way Spray

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE   PRO FORMULA
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-008
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	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54273-008-01	96 g in 1 CAN; Type 0: Not a Combination Product	09/24/2018
2	NDC: 54273-008-02	116 g in 1 CAN; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	09/24/2018

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)