ZIMS MAX FREEZE

Manufacturer
KOBAYASHI Healthcare International, Inc.
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:09:14

Label at a glance#

ProductZIMS MAX FREEZE LEG CRAMPS
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Bruises Sprains Cramps

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: 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
Camphor 5%Topical analgesic
Menthol 5%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
  • Cramps

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch on your leg or arm at a time
  • 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 adhering patch to clothes or delicate fabrics such as silk

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:

  • 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

Butyl Acrylate/Methacrylic acid copolymer, FD&C Blue No. 1, Glycerin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylparaben, Propylene glycol, Silicon dioxide, Sodium polyacrylate, Sodium polyacrylate starch, Sorbitan monooleate, Sorbitol, Tartaric acid, Water

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZIM'S™
MAX-
FREEZE

For Minor Pain Caused by
LEG CRAMPS
COOLING PAIN RELIEF HYDRO PATCH

Immediate Cooling & Long-lasting
Pain Relief
While You Sleep*†

APPLY for
8
Hours

5 PATCHES

3 15/16" X 5 1/2" (10 cm X 14 cm)
†See back panel for important product information

COOLING PAIN RELIEF HYDRO PATCH: Menthol & Camphor with thick Hydrogel

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box
PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2675766camphor 5 % / menthol 5 % Medicated PatchPSN2
2675766camphor 0.05 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD2
2675766camphor 5 % / menthol 5 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54273-013-01ZIMS MAX FREEZE LEG CRAMPS5 in 1 BOXPATCH52
54273-013-01ZIMS MAX FREEZE LEG CRAMPS1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54273-013ZIMS MAX FREEZE LEG CRAMPS (CAMPHOR, MENTHOL) PATCH [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]2Current NDC, 2 package rows20240301_ba26635d-95d3-4d88-93cc-1fd4fd29fd79.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54273-01354273-013-01

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 FREEZE LEG CRAMPSCAMPHOR, MENTHOLKOBAYASHI Healthcare International, Inc.ba26635d-95d3-4d88-93cc-1fd4fd29fd792024-01-18WarningsExact identifier
ndc (package): 54273-013-01
ndc (product): 54273-013
ndc11 (package): 54273001301
spl id: 79f7f390-473d-4cc5-87df-74def2114c8a
spl set id: ba26635d-95d3-4d88-93cc-1fd4fd29fd79

Reported adverse events (FAERS/openFDA)#

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