Drug Facts

Active ingredient

Menthol 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

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

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

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:

apply to affected area using roller ball not more than 4 times daily
massage painful area until absorbed into skin
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

1Aloe Barbadensis Leaf Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Arnica Extract, Isopropyl Alcohol, Propylene Glycol, Tea Tree Oil, Vanillyl Butyl Ether, Water.

1: Symbol before the ingredient indicates certified organic.

Consumer Comments Call:
1-800-432-8629

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

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

EXTRA STRENGTH

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING* -
PAIN RELIEF

-: FAST ACTING
-: LONG LASTING
-: VANISHING SCENT

COLD THERAPY
COOLING ROLL-ON
with 7% Menthol

Net Wt 3oz (85g)

*compared to original

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

ZIMS MAX FREEZE PRO FORMULA
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54273-007
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	70 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TEA TREE OIL (UNII: VIF565UC2G)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54273-007-01	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/01/2018
2	NDC:54273-007-02	102 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M017	08/01/2018

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)

Registrant - KOBAYASHI America Manufacturing, LLC (079852150)

Name	Address	ID/FEI	Business Operations
Establishment
KOBAYASHI America Manufacturing, LLC		079852150	PACK(54273-007) , LABEL(54273-007)

ZIM'S™ MAX FREEZE PRO FORMULA