Zims Max Freeze Gel
FDA Label NDC 54273-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kobayashi Healthcare International, Inc. for the product Zims Max Freeze (NDC 54273-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, flammable, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

Active Ingredient

Menthol 7%

Purpose

Topical Analgesic

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

For external use only

Flammable

Keep away from fire or flame and heated surfaces

Do Not Use

  • 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

  • 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

  • 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

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

Otc - Keep Out Of Reach Of Children

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

Other Information

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

Inactive Ingredients

†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

Consumer Comments Call:
800-319-2225

Principal Display Panel - 85 G Bottle Label

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

* Please review the disclaimer below.