FDA.reportPublic FDA data

ZIMS MAX FREEZE

Manufacturer
KOBAYASHI Healthcare International, Inc.
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:02:19

Label at a glance#

ProductZIMS MAX FREEZE PRO FORMULA
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 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

Dosage and administration

Adults and children 12 years of age and over: apply to affected area not more than 4 times daily Children under 12 years of age: consult a doctor

Storage and handling

store in a cool place away from direct sunlight store with cap closed tightly

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Flammable

SPL UNCLASSIFIED SECTION

Keep away from fire or flame and heated surfaces

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • to avoid excess application, press applicator gently against skin
  • 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

OTC - STOP USE SECTION

  • 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

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. 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:

  • apply to affected area not more than 4 times daily

Children under 12 years of age:

  • consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

†Aloe Barbadensis Leaf Extract, Arnica Extract, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Vanillyl Butyl Ether, Water.

†Symbol before the ingredient indicates certified organic.

OTC - QUESTIONS SECTION

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 - 89 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZIM'S™
MAX-
FREEZE
PRO FORMULA

DEEP PENETRATING
PAIN RELIEF

- FAST ACTING
- LONG LASTING
- VANISHING SCENT

Bottle Shaped for
Easy Application

COLD THERAPY
COOLING LIQUID
with 16% Menthol

3 fl oz (89mL)

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866084menthol 16 % Topical SolutionPSN9
866084menthol 160 MG/ML Topical SolutionSCD9
866084menthol 16 % Topical SolutionSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54273-009-01ZIMS MAX FREEZE PRO FORMULA89 mL in 1 BOTTLE, WITH APPLICATORLIQUID899
54273-009-01ZIMS MAX FREEZE PRO FORMULA1 in 1 CARTONLIQUID19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54273-009ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]9Current NDC, Legacy NDC, 2 package rows20231117_4d91baf3-9655-4786-93b8-aa0d93fe0bf9.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54273-00954273-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
TEA TREE OILVIF565UC2GIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML · Source PDF

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 PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
ndc (package): 54273-009-01
ndc (product): 54273-009
ndc11 (package): 54273000901
spl id: 171be518-73bb-4425-9565-1545166d3f51
spl set id: 4d91baf3-9655-4786-93b8-aa0d93fe0bf9

Reported adverse events (FAERS/openFDA)#

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