Zims Max Freeze Spray
FDA Label NDC 54273-008

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 54273-008). 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

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

Active Ingredient

Menthol 16%

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 near sparks or while smoking
  • do not use in a small or confined space
  • avoid long term storage above 104° F (40° C)
  • do not puncture or incinerate. Contents under pressure.
  • do not expose to temperature exceeding 119° F (48° C)

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
  • near face
  • 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
  • avoid inhalation
  • menthol may cause a cold or burning sensation wherever it is applied, but is usually mild and gradually lessens over time
  • if severe burning sensation occurs, discontinue use immediately

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.

Directions

Adults and children 12 years of age and over:

  • spray affected area not more than 4 times daily
  • no need to rub
  • 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 locked tightly

Inactive Ingredients

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

†Symbol before the ingredient indicates certified organic

Otc - Questions

Consumer Comments Call:
1-800-432-8629

Principal Display Panel - 96 G Can Label

IMPROVED

ZIM'S™
MAX-
FREEZE

PRO FORMULA

- LONGER LASTING* -
PAIN RELIEF

  • -FAST ACTING
  • -LONG LASTING
  • -VANISHING SCENT

    • CONTINUOUS
    COOLING SPRAY
    with 16% Menthol

    Net Wt 3.4oz (96g)
    *compared to original

    Continuous
    Multi-Way Spray

* Please review the disclaimer below.