FDA.reportPublic FDA data

ZIMS MAX FREEZE

Manufacturer
KOBAYASHI Healthcare International, Inc. | KOBAYASHI America Manufacturing, LLC
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:21

Label at a glance#

ProductZIMS MAX FREEZE LEG CRAMP
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
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: apply to affected area not more than 4 times daily Children under 12 years of age: consult a doctor

Storage and handling

allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use store in a cool place away from direct sunlight store with cap closed tightly

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose  
Camphor 3.1%Topical analgesic
Menthol 5%Topical analgesic
Methyl Salicylate 11.5%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

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
  • after expiration date

When using this product

OTC - WHEN USING SECTION

  • to avoid excess application, press applicator gently against skin
  • do not bandage tightly or cover with wrap or use heating pad or TENS device
  • do not use 1 hour prior to bathing or within 30 minutes after bathing
  • do not use other 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, burning sensation, swelling or blistering 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 you are pregnant or breastfeeding, 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 immediately.

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

  • allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use
  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dimethyl Isosorbide, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Tocopheryl Acetate, Water, Zingiber Officinale (Ginger) Root Extract.

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

For Minor Pain Caused by
LEG CRAMPS

Relax & Relieve
Muscles

Fast Acting
Liquid

Easy to Use
Angled Bottle

Pain Relieving
Liquid
3 fl oz (89mL)

3 POWERFUL INGREDIENTS

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
2610291camphor 3.1 % / menthol 5 % / methyl salicylate 11.5 % Topical SolutionPSN3
2610291camphor 31 MG/ML / menthol 50 MG/ML / methyl salicylate 115 MG/ML Topical SolutionSCD3
2610291camphor 3.1 % / menthol 5 % / methyl salicylate 11.5 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54273-011-01ZIMS MAX FREEZE LEG CRAMP89 mL in 1 BOTTLE, WITH APPLICATORLIQUID893
54273-011-01ZIMS MAX FREEZE LEG CRAMP1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54273-011ZIMS MAX FREEZE LEG CRAMP (MENTHOL) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 2 package rows20231117_7ef03298-6623-4cf4-b21f-74b2ffc11c6e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54273-01154273-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
DIMETHYL ISOSORBIDESA6A6V432SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
TEA TREE OILVIF565UC2GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
GINGERC5529G5JPQIACT

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 CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
ndc (package): 54273-011-01
ndc (product): 54273-011
ndc11 (package): 54273001101
spl id: 223b6899-de24-47f9-842b-588689ab1a41
spl set id: 7ef03298-6623-4cf4-b21f-74b2ffc11c6e

Reported adverse events (FAERS/openFDA)#

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