Zims Max Freeze Patch
FDA Label NDC 54273-012

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 54273-012). 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
Lidocaine HCl 4%Topical anesthetic
Menthol 1%Topical analgesic

Uses

For the temporary relief of pain

Warnings

For external use only

Do Not Use

  • more than 1 patch on your body 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 contact with silk
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the active ingredients that can produce serious adverse effects if a child or pet chews or ingests this patch

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 cool place away from direct sunlight

Inactive Ingredients

FD&C Blue No. 1, Glycerin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Polyvinyl Alcohol, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Oleate, Sorbitol, Tartaric Acid, Vanillyl Butyl Ether, Water

Principal Display Panel - 3 Patch Pouch Box

ZIM'S™
MAX-
FREEZE

LIDOCAINE 4%
PAIN RELIEF PATCH

FREEZING SENSATION

NUMBS
AWAY PAIN

Fast Acting & Long Lasting
Hydrated Gel Patch

3 PATCHES

3 15/16" X 5 1/2"
(10 cm X 14 cm)
Individually Packaged

LIDOCAINE 4% & MENTHOL 1%

Principal Display Panel (3 Patch Pouch Box)

Principal Display Panel (3 Patch Pouch Box)

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