ELEVATE COOLING THERAPY TWIST UP- menthol 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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elevate COOLING THERAPY TWIST UP

Menthol

Stop use and ask 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.

Purpose

Topical Analgesic

Questions? Call 215.660.9123 or email us at info@elevatecbd.com

When using this product

Other information

elevate CBD COOLING THERAPY TWIST UP TOPICAL with Menthol

Uses

Massage desired amount into affected skin area no more than 10 times daily or as directed by your doctor.

children under 12 years of age consult your physician.

Warnings

Inactive Ingredients

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Mint Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid

elevate Twist Up Topical label

2oz stick label

ELEVATE COOLING THERAPY TWIST UP 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-456
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
WITCH HAZEL (UNII: 101I4J0U34)  
SHEA BUTTER (UNII: K49155WL9Y)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WHITE WAX (UNII: 7G1J5DA97F)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
CORN OIL (UNII: 8470G57WFM)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-456-0156 g in 1 APPLICATOR; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2019
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-456)

Revised: 1/2022
Document Id: d57c85bc-4eb0-3fc9-e053-2a95a90a3917
Set id: 9a13830b-b8b0-276e-e053-2995a90a3573
Version: 2
Effective Time: 20220113
 
Renu Laboratories, Inc.