ZIMS MAX FREEZE- menthol, unspecified form gel
KOBAYASHI Healthcare International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ZIM'S™ MAX FREEZE

Drug Facts

SHAKE WELL

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
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.

Directions

Adults and children 12 years of age and over:

apply to affected area 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 lid closed tightly

Inactive ingredients

1Aloe Barbadensis Leaf Extract, 1Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, 1Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

1: Symbol before the ingredient indicates certified organic.

Consumer Comments Call: 800-319-2225

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

PRINCIPAL DISPLAY PANEL - 113 g Tube 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.

COOLING GEL
with Menthol

Net Wt 4oz. (113g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

ZIMS MAX FREEZE
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54273-002
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54273-002-01	113 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2017	12/31/2022
2	NDC:54273-002-02	136 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2017	12/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	09/01/2017	12/31/2022

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(54273-002) , LABEL(54273-002)

Revised: 12/2022

Document Id: fe7209f5-f53c-48d0-af53-0eab04cd4616

Set id: 325971b2-2759-4b84-98bf-4ca6c7ff6dbd

Version: 5

Effective Time: 20221206

KOBAYASHI Healthcare International, Inc.