Zims Max Freeze Patch
FDA Label NDC 54273-013

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 54273-013). 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, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, 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

Otc - Purpose

Active ingredientsPurpose
Camphor 5%Topical analgesic
Menthol 5%Topical analgesic

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
  • Cramps

Warnings

For external use only

Do Not Use

  • more than 1 patch on your leg or arm at a time
  • if you are allergic to any ingredients in this product
  • on open wounds, damaged or irritated skin
  • with a heating pad or TENS device or other topical analgesics
  • 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
  • may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
  • if severe burning sensation occurs, discontinue use immediately
  • may leave a blue stain on skin, which is safe and can be removed by washing with soap and water
  • avoid adhering patch to clothes or delicate fabrics such as silk

Stop Use And Ask A Doctor If

  • burning sensation is painful and persistent
  • condition worsens
  • rash, itching, redness, swelling, blistering 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 and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to the skin (see illustration)
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily

    • Children under 12 years of age:

    • consult a doctor

Other Information

  • store in a place away from direct sunlight and excessive heat and moisture.

Inactive Ingredients

Butyl Acrylate/Methacrylic acid copolymer, FD&C Blue No. 1, Glycerin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylparaben, Propylene glycol, Silicon dioxide, Sodium polyacrylate, Sodium polyacrylate starch, Sorbitan monooleate, Sorbitol, Tartaric acid, Water

Principal Display Panel - 5 Patch Pouch Box

ZIM'S™
MAX-
FREEZE

For Minor Pain Caused by
LEG CRAMPS
COOLING PAIN RELIEF HYDRO PATCH

Immediate Cooling & Long-lasting
Pain Relief
While You Sleep*†

APPLY for
8
Hours

5 PATCHES

3 15/16" X 5 1/2" (10 cm X 14 cm)
†See back panel for important product information

COOLING PAIN RELIEF HYDRO PATCH: Menthol & Camphor with thick Hydrogel

Principal Display Panel (5 Patch Pouch Box)

Principal Display Panel (5 Patch Pouch Box)

* Please review the disclaimer below.