MAG 5 PT WARMING FORMULA- menthol cream

MAG 5 PT WARMING FORMULA by

Drug Labeling and Warnings

MAG 5 PT WARMING FORMULA 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

INDICATIONS & USAGE

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

WARNINGS

For external use only

WHEN USING

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 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

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 10 times a day or as directed by your physical or occupational therapist
• children under 12 years of age, do not use, consult a doctor.

INACTIVE INGREDIENT

Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hemp Derived Cannabidiol (CBD) Extract, Laureth-7, Lobelia Inflata (Lobelia) Extract, Magnesium Chloride, Magnesium Citrate, Magnesium Gluconate, Magnesium Myristate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), Phenoxyethanol, Polyacrylamide C13-14 Isoparaffin, Xanthan Gum

PRINCIPAL DISPLAY PANEL

MAG 5 PT JAR LABEL AND BOX

INGREDIENTS AND APPEARANCE

MAG 5 PT WARMING FORMULA 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-511
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
LOBELIA INFLATA LEAF (UNII: 7QFT17RLRG)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCONUT OIL (UNII: Q9L0O73W7L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
TABASCO PEPPER (UNII: J1M3NA843L)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
NIACINAMIDE (UNII: 25X51I8RD4)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CORN OIL (UNII: 8470G57WFM)
MAGNESIUM OROTATE (UNII: GI96W46M5A)
CANNABIDIOL (UNII: 19GBJ60SN5)
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEG-100 STEARATE (UNII: YD01N1999R)
WITCH HAZEL (UNII: 101I4J0U34)
SHEA BUTTER (UNII: K49155WL9Y)
LAURETH-7 (UNII: Z95S6G8201)
PEPPERMINT OIL (UNII: AV092KU4JH)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
WHITE WAX (UNII: 7G1J5DA97F)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-511-05	1 in 1 BOX	03/19/2019
1	NDC: 76348-511-04	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(76348-511)