MAGNIFICENT MENTHOL WARMING CREAM- menthol cream cream 
RENU LABORATORIES, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

MagNificent Menthol Warming Pain Cream

Active Ingredient:

Menthol 5%

Topical Analgesic

Warnings

For external use only

When using this product

Do not bandage tightly

Stop use and ask a doctor if

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

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

Manufactured for:

X12LLC West Chester, PA 19380

www.Magx12.com

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 top labelMagnificent_Round_Warming_CBD (2).jpg

Magnificent Warming BoxMAGNIFICENT WARMING LABEL

MAGNIFICENT_warming_Layered Label_FINALCorrected (2).jpg

MAGNIFICENT MENTHOL WARMING CREAM 
menthol cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-422
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
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)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
WITCH HAZEL (UNII: 101I4J0U34)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LAURETH-7 (UNII: Z95S6G8201)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-422-021 in 1 BOX02/18/2019
1NDC:76348-422-01112 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/18/2019
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-422)

Revised: 1/2022
Document Id: d5900c5f-b18c-3ff5-e053-2995a90af7cc
Set id: 8506740a-3f42-a49f-e053-2a91aa0a0ac0
Version: 2
Effective Time: 20220114
 
RENU LABORATORIES, INC.