ZIMS MAX FREEZE- menthol, unspecified form gel

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

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.

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 - 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)

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-002
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (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)

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