MAG 5 PT COOLING FORMULA RECOVERY CREAM- menthol cream

Mag 5 PT Cooling Formula Recovery Cream by

Drug Labeling and Warnings

Mag 5 PT Cooling Formula Recovery Cream by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 5%

PURPOSE

Topical Analgesic

WARNINGS

For external use only

WHEN USING

Do not bandage tightly

avoid contact with eyes

do not apply to wounds or damaged skin

do not use with heating pads or other heatng 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

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

DOSAGE & ADMINISTRATION

Directions Adults and children 12 years of age and older, apply to affected area no more than three 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, 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, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (vegetable), Phenoxyethanol, Polyacrylamide, Xanthan Gum

QUESTIONS

Visit us on the web www.mag5pt.com

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

PRODUCT LABEL AND PRODUCT BOX

INGREDIENTS AND APPEARANCE

MAG 5 PT COOLING FORMULA RECOVERY CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.6 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)
MAGNESIUM OROTATE (UNII: GI96W46M5A)
WITCH HAZEL (UNII: 101I4J0U34)
NIACINAMIDE (UNII: 25X51I8RD4)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PEG-100 STEARATE (UNII: YD01N1999R)
OLIVE OIL (UNII: 6UYK2W1W1E)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
PEPPERMINT OIL (UNII: AV092KU4JH)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
CORN OIL (UNII: 8470G57WFM)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WHITE WAX (UNII: 7G1J5DA97F)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCONUT OIL (UNII: Q9L0O73W7L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-510-05	1 in 1 BOX	03/19/2019
1	NDC: 76348-510-04	112 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/19/2019

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-510)