ZIMS MAX FREEZE PRO FORMULA- 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

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 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, Hydroxypropylcellulose, Isopropyl Alcohol, Propylene Glycol, 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 - 113 g Tube Label

EXTRA STRENGTH

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING* -
PAIN RELIEF

- FAST ACTING
- LONG LASTING
- VANISHING SCENT

COLD THERAPY
COOLING GEL
with 7% Menthol

Net Wt 4oz (113g)

*compared to original

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE   PRO FORMULA
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-006
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	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TEA TREE OIL (UNII: VIF565UC2G)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54273-006-01	113 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2018
2	NDC: 54273-006-02	136 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2019
3	NDC: 54273-006-03	5 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	07/01/2018

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)