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

Purpose

Topical Analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only

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

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
Purpose

Topical Analgesic

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.

Description

Drug Facts

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.

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%

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

Warnings

For external use only

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

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
Purpose

Topical Analgesic

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.

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.

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%

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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