Zims Max Freeze Gel
FDA Label NDC 54273-006

15 label sections · Submitted to the FDA by Kobayashi Healthcare International, Inc. · 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 54273-006). 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, do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

Flammable: Keep away from fire or flame and heated surfaces

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

Rare cases of burns have been reported with products of this type

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

  • may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes

Otc - Stop Use

Stop use and ask a doctor if

  • burning sensation is painful and persistent
  • 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.

Directions

  • Adults and children 12 years of age and over:
    • apply to affected area 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

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

Inactive Ingredients

Symbol before the ingredient indicates certified organic.

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

Otc - Questions

Consumer Comments Call: 1-800-432-8629

Principal Display Panel - 113 G Tube Label

EXTRA STRENGTH

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING* -
PAIN RELIEF

- FAST ACTING
- LONG LASTING
- VANISHING SCENT

COLD THERAPY
COOLING GEL
with 7% Menthol

Net Wt 4oz (113g)

*compared to original

Principal Display Panel (113 g Tube Label)

Principal Display Panel (113 g Tube Label)

* Please review the disclaimer below.