Mag 5 Pt Roll-on Pain Relief Cooling

Mag 5 Pt Roll-on Pain Relief Cooling
SPL v2
SPL
SPL Set ID 31e4fa2c-3a98-d618-e063-6394a90aec1c
Route
TOPICAL
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.2 g)
Inactive Ingredients
Magnesium Gluconate Anhydrous Magnesium Orotate Magnesium Sulfate Arnica Montana Flower Lobelia Inflata Cannabis Sativa Seed Oil Cannabidiol Mentha Piperita (peppermint) Oil Water Sodium Benzoate Magnesium Myristate Polysorbate 80 Methylcellulose Isopropyl Alcohol Hamamelis Virginiana Top Water Magnesium Chloride Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-03

Description

Active Ingredient: Menthol 5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist - children under 12 years of age consult your physical or occupational therapist.

Dosage and Administration

Uses

For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

Description

Active Ingredient: Menthol 5%

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50567-7

When using this product

  • Do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices
Section 51727-6

Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Laureth-7, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Magifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Polyacrylamide, Xanthan Gum

Section 51945-4

MAG 5 PT COOLING ROLL-ON LABEL AND BOX ART

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active Ingredient: Menthol 5%


Structured Label Content

Indications and Usage (34067-9)

Directions

Adults and children 12 years of age and older, apply to affected area no more than 10 times a day or as directed by your physical or occupational therapist - children under 12 years of age consult your physical or occupational therapist.

Dosage and Administration (34068-7)

Uses

For temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

Warnings and Precautions (34071-1)

Warnings

For external use only

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 50566-9 (50566-9)

Stop use and ask a doctor if

Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product

  • Do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices
Section 51727-6 (51727-6)

Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Laureth-7, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Magifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Polyacrylamide, Xanthan Gum

Section 51945-4 (51945-4)

MAG 5 PT COOLING ROLL-ON LABEL AND BOX ART

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active Ingredient: Menthol 5%


Advanced Ingredient Data


Raw Label Data

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