MAG 5 PT ROLL-ON PAIN RELIEF COOLING- menthol liquid

MAG 5 PT ROLL-ON PAIN RELIEF COOLING by

Drug Labeling and Warnings

MAG 5 PT ROLL-ON PAIN RELIEF COOLING by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Menthol 5%

PURPOSE

Purpose

Topical analgesic

DOSAGE & ADMINISTRATION

Uses

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

WARNINGS

Warnings

For external use only

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

INDICATIONS & 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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

MAG 5 PT COOLING ROLL-ON LABEL AND BOX ART

INGREDIENTS AND APPEARANCE

MAG 5 PT ROLL-ON PAIN RELIEF COOLING 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-517
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.2 g  in 84 g

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM GLUCONATE ANHYDROUS (UNII: TH52F4317B)
MAGNESIUM OROTATE (UNII: GI96W46M5A)
MAGNESIUM SULFATE (UNII: DE08037SAB)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LOBELIA INFLATA (UNII: 9PP1T3TC5U)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANNABIDIOL (UNII: 19GBJ60SN5)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYLCELLULOSE (UNII: Z944H5SN0H)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-517-02	1 in 1 BOX	04/03/2025
1	NDC: 76348-517-03	84 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 76348-517-01	1 in 1 BOX	04/03/2025
2	NDC: 76348-517-03	84 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/03/2025

Labeler - RENU LABORATORIES, LLC (119451815)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, LLC		119451815	manufacture(76348-517)