Zim's™ Max Freeze

Zim's™ Max Freeze
SPL v5
SPL
SPL Set ID 08dcfa78-7332-4f19-90d7-fdd7d446848a
Route
TOPICAL
Published
Effective Date 2019-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (160 mg)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Whole Vanillyl Butyl Ether Tea Tree Oil Glycerin Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-24

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53413-1

Consumer Comments Call:

1-800-432-8629

Section 53414-9

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

Warnings

For external use only

Rare cases of burns have been reported with products of this type

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
Active Ingredient

Menthol 16%

Other Information
  • store in a cool place away from direct sunlight
  • store with cap locked tightly
Inactive Ingredients

Symbol before the ingredient indicates certified organic.
Aloe Barbadensis Leaf Extract, Arnica Extract, Glycerin, SD Alcohol 40-B, Tea Tree Oil, Vanillyl Butyl Ether, Water.

When Using This Product
  • may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes
  • avoid inhalation
Stop Use and Ask A Doctor If
  • burning sensation is painful and persistent
  • 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
Children Under 12 Years of Age
  • consult a doctor
Principal Display Panel 96 G Can Label

EXTRA STRENGTH

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

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

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53413-1 (53413-1)

Consumer Comments Call:

1-800-432-8629

Section 53414-9 (53414-9)

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

Purpose

Topical Analgesic

Warnings

For external use only

Rare cases of burns have been reported with products of this type

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 (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
Active Ingredient (Active ingredient)

Menthol 16%

Other Information (Other information)
  • store in a cool place away from direct sunlight
  • store with cap locked tightly
Inactive Ingredients (Inactive ingredients)

Symbol before the ingredient indicates certified organic.
Aloe Barbadensis Leaf Extract, Arnica Extract, Glycerin, SD Alcohol 40-B, Tea Tree Oil, Vanillyl Butyl Ether, Water.

When Using This Product (When using this product)
  • may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes
  • avoid inhalation
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 or excessive irritation of the skin develops
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Children Under 12 Years of Age (Children under 12 years of age)
  • consult a doctor
Principal Display Panel 96 G Can Label (PRINCIPAL DISPLAY PANEL - 96 g Can Label)

EXTRA STRENGTH

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

Adults and Children 12 Years of Age and Over (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

Advanced Ingredient Data


Raw Label Data

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