FDA.reportPublic FDA data

ZIMS MAX FREEZE

Manufacturer
KOBAYASHI Healthcare International, Inc. | KOBAYASHI America Manufacturing, LLC
Effective date
2022-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:44:50

Label at a glance#

ProductZIMS MAX FREEZE
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 using roller ball not more than 4 times daily massage painful area until absorbed into skin wash hands after each use with cold water Children under 12 years of age: consult a doctor

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 7%

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

  • 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 using roller ball not more than 4 times daily
  • massage painful area until absorbed into skin
  • wash hands after each use with cold water

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 lid closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

†Aloe Barbadensis Leaf Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, †Arnica Extract, Isopropyl Alcohol, Propylene Glycol, Tea Tree Oil, Vanillyl Butyl Ether, Water.

†Symbol before the ingredient indicates certified organic.

OTC - QUESTIONS SECTION

Consumer Comments Call: 800-319-2225

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPROVED

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING* -
PAIN RELIEF

- FAST ACTING
- LONG LASTING
- VANISHING SCENT

COLD THERAPY
COOLING ROLL-ON
with 7% Menthol

Net Wt 3oz. (85g)

*compared to original

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54273-00354273-003-01, 54273-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TEA TREE OILVIF565UC2GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
bf986fce-39c7-4db7-9cc7-5242325dd156208d7902-6a97-4534-947b-45cbc8f9051c2022-12-09WarningsExact identifier
spl id: bf986fce-39c7-4db7-9cc7-5242325dd156
spl set id: 208d7902-6a97-4534-947b-45cbc8f9051c

Reported adverse events (FAERS/openFDA)#

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