MAGNIFICENT MENTHOL WARMING CREAM- menthol cream cream

MagNificent Menthol Warming Cream by

Drug Labeling and Warnings

MagNificent Menthol Warming Cream by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC., Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Menthol 5%

PURPOSE

Topical Analgesic

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.

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.

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

Inactive Ingredients:

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil and Hemp Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Citrus Paradisi (Grapefruit) Extract, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Hamamelis Virginiana (Witch Hazel), Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), Phenoxyethanol, Xanthan Gum

QUESTIONS

Manufactured for:

X12LLC West Chester, PA 19380

www.Magx12.com

INDICATIONS & USAGE

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

MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg Magnificent_Round_Warming_CBD (2).jpg Magnificent-WARMING CBD_ART_Box_112718 (2).jpg

Magnificent_Round_Warming_CBD (2).jpg

MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg

INGREDIENTS AND APPEARANCE

MAGNIFICENT MENTHOL WARMING CREAM 
menthol cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-422
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
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
OLIVE OIL (UNII: 6UYK2W1W1E)
CANNABIDIOL (UNII: 19GBJ60SN5)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CORN OIL (UNII: 8470G57WFM)
WHITE WAX (UNII: 7G1J5DA97F)
PEPPERMINT OIL (UNII: AV092KU4JH)
CAPSICUM (UNII: 00UK7646FG)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WITCH HAZEL (UNII: 101I4J0U34)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURETH-7 (UNII: Z95S6G8201)
GRAPEFRUIT OIL (UNII: YR377U58W9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-422-02	1 in 1 BOX	02/18/2019
1	NDC: 76348-422-01	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	02/18/2019

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-422)