Zim's™ Max Freeze

Zim's™ Max Freeze
SPL v4
SPL
SPL Set ID e364ff83-4aaf-4897-a7da-06581bc321f2
Route
TOPICAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (760 mg)
Inactive Ingredients
Sodium Polyacrylate Starch (400 Micrometer Particle) Fd&c Blue No. 1 Glycerin Methylparaben Polyacrylic Acid (300000 Mw) Polyvinyl Alcohol, Unspecified Povidone, Unspecified Propylene Glycol Propylparaben Sodium Polyacrylate (2500000 Mw) Sorbitan Monooleate Sorbitol Tartaric Acid Vanillyl Butyl Ether Water Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-10

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

For the temporary relief of pain

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Lidocaine HCl 4% Topical anesthetic
Menthol 1% Topical analgesic
Warnings

For external use only

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:

  • do not use, consult a doctor
Do Not Use
  • more than 1 patch on your body at a time
  • in large quantities, particularly over raw surfaces or blistered areas
  • 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
Other Information
  • store in a place away from direct sunlight and excessive heat and moisture
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

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
Principal Display Panel 3 Patch Pouch Box

ZIM'S™

MAX-

FREEZE

MAXIMUM STRENGTH LIDOCAINE 4%

PAIN RELIEF PATCH

FREEZING SENSATION

NUMBS

AWAY PAIN

LONG LASTING

FAST ACTING

Apply

up to

8 hours

MAX HYDROGEL

TECHNOLOGY

40% THICKER*

FOR MAX COMFORT

3 PATCHES

3 15/16" X 5 1/2"

(10 cm X 14 cm)

Individually Packaged

LIDOCAINE 4% & MENTHOL 1%

†without a prescription


Structured Label Content

Uses

For the temporary relief of pain

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Lidocaine HCl 4% Topical anesthetic
Menthol 1% Topical analgesic
Warnings

For external use only

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:

  • do not use, consult a doctor
Do Not Use (Do not use)
  • more than 1 patch on your body at a time
  • in large quantities, particularly over raw surfaces or blistered areas
  • 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
Other Information (Other information)
  • store in a place away from direct sunlight and excessive heat and moisture
Inactive Ingredients (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

When Using This Product (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 (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
Principal Display Panel 3 Patch Pouch Box (PRINCIPAL DISPLAY PANEL - 3 Patch Pouch Box)

ZIM'S™

MAX-

FREEZE

MAXIMUM STRENGTH LIDOCAINE 4%

PAIN RELIEF PATCH

FREEZING SENSATION

NUMBS

AWAY PAIN

LONG LASTING

FAST ACTING

Apply

up to

8 hours

MAX HYDROGEL

TECHNOLOGY

40% THICKER*

FOR MAX COMFORT

3 PATCHES

3 15/16" X 5 1/2"

(10 cm X 14 cm)

Individually Packaged

LIDOCAINE 4% & MENTHOL 1%

†without a prescription


Advanced Ingredient Data


Raw Label Data

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