ZIMS MAX FREEZE- lidocaine hydrochloride and menthol, patch

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

Active ingredients	Purpose
Lidocaine HCl 4%	Topical anesthetic
Menthol 1%	Topical analgesic

Uses

For the temporary relief of pain

Warnings

For external use only

Do not use

• more than 1 patch on your body at a time
• in large quantities, particularly over raw surfaces or blistered areas
• if you are allergic to any ingredients in this product
• on open wounds, damaged or irritated skin
• with a heating pad or TENS device or other topical analgesics
• 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
• may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
• if severe burning sensation occurs, discontinue use immediately
• may leave a blue stain on skin, which is safe and can be removed by washing with soap and water
• avoid contact with silk
• dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the active ingredients that can produce serious adverse effects if a child or pet chews or ingests this patch

Stop use and ask a doctor if

• burning sensation is painful and persistent
• condition worsens
• rash, itching, redness, swelling, blistering 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 and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

• clean and dry affected area
• remove film from patch and apply to the skin (see illustration)
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily

Children under 12 years of age:

• do not use, consult a doctor

Other information

• store in a place away from direct sunlight and excessive heat and moisture

Inactive ingredients

FD&C Blue No.1, Glycerin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Polyvinyl Alcohol, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Oleate, Sorbitol, Tartaric Acid, Vanillyl Butyl Ether, Water

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 3 Patch Pouch Box

ZIM'S™
MAX-
FREEZE

MAXIMUM STRENGTH LIDOCAINE 4%†
PAIN RELIEF PATCH

FREEZING SENSATION

NUMBS
AWAY PAIN

LONG LASTING

FAST ACTING

Apply
up to
8 hours

MAX HYDROGEL
TECHNOLOGY

40% THICKER*
FOR MAX COMFORT

3 PATCHES

3 15/16" X 5 1/2"
(10 cm X 14 cm)
Individually Packaged

LIDOCAINE 4% & MENTHOL 1%

†without a prescription

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE 
lidocaine hydrochloride and menthol, patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	760 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	190 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE STARCH (400 MICROMETER PARTICLE) (UNII: Y58AEZ2NBY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54273-012-01	3 in 1 BOX	05/10/2023
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	05/10/2023

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)