Zim's™ Max-freeze

Zim's™ Max-freeze
SPL v2
SPL
SPL Set ID ba26635d-95d3-4d88-93cc-1fd4fd29fd79
Route
TOPICAL
Published
Effective Date 2024-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (950 mg) Menthol, Unspecified Form
Inactive Ingredients
Butyl Acrylate/methacrylic Acid Copolymer (2% Methacrylic Acid) Fd&c Blue No. 1 Glycerin Methylparaben Polyacrylic Acid (300000 Mw) Polysorbate 80 Polyvinyl Alcohol, Unspecified Propylene Glycol Propylparaben Sodium Polyacrylate (2500000 Mw) Sodium Polyacrylate Starch (25 Micrometer Particle) Sorbitan Monooleate Sorbitol Tartaric Acid Silicon Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
  • Cramps
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
Camphor 5% Topical analgesic
Menthol 5% 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:

  • consult a doctor
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
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

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
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


Structured Label Content

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
  • Cramps
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
Camphor 5% Topical analgesic
Menthol 5% 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:

  • consult a doctor
Do Not Use (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
Other Information (Other information)
  • store in a place away from direct sunlight and excessive heat and moisture.
Inactive Ingredients (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

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 adhering patch to clothes or delicate fabrics such as silk
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 5 Patch Pouch Box (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)