MAGNIFICENT MENTHOL COOLING PAIN CREAM- menthol topical analgesic 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.

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MagNificent Menthol Cooling Pain Cream

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Warnings

For external use only

When using this product

Do not bandage tightly

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.

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 physicial or occupational therapist

Inactive Ingredients:

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, 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

Cooling Side Label

Cooling top label

BOX

Uses

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

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.

MagNificent Box

MAGNIFICENT MENTHOL COOLING PAIN CREAM 
menthol topical analgesic cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-421
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
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CORN OIL (UNII: 8470G57WFM)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
LAURETH-7 (UNII: Z95S6G8201)  
SHEA BUTTER (UNII: K49155WL9Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WHITE WAX (UNII: 7G1J5DA97F)  
WITCH HAZEL (UNII: 101I4J0U34)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
WATER (UNII: 059QF0KO0R)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-421-01112 g in 1 JAR; Type 0: Not a Combination Product12/06/2018
2NDC:76348-421-02112 g in 1 BOX; Type 0: Not a Combination Product12/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/06/2018
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-421)

Revised: 1/2022
Document Id: d5900d6e-42fe-54a3-e053-2995a90a61af
Set id: 7c5f5818-0a0b-556a-e053-2991aa0a69cc
Version: 2
Effective Time: 20220114
 
Renu Laboratories, Inc.