ZIMS MAX FREEZE

Manufacturer
KOBAYASHI Healthcare International, Inc.
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:27:00

Label at a glance#

ProductZIMS MAX FREEZE
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lidocaine HCl 4%Topical anesthetic
Menthol 1%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel - 3 Patch Pouch Box
Principal Display Panel - 3 Patch Pouch Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchPSN4
1373130lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD4
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54273-012-01ZIMS MAX FREEZE3 in 1 BOXPATCH34
54273-012-01ZIMS MAX FREEZE1 in 1 POUCHPATCH14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54273-01254273-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIMS MAX FREEZELIDOCAINE HYDROCHLORIDE AND MENTHOL,KOBAYASHI Healthcare International, Inc.e364ff83-4aaf-4897-a7da-06581bc321f22025-12-18WarningsExact identifier
ndc (package): 54273-012-01
ndc (product): 54273-012
ndc11 (package): 54273001201
spl id: d2b1f3a9-2b7b-4462-afd0-1a19e72981da
spl set id: e364ff83-4aaf-4897-a7da-06581bc321f2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.