ELEVATE HEATING THERAPY- 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 HEATING THERAPY TOPICAL CREAM

Menthol 5 percent

Warnings

For external use only

When using this product do not bandage tightly

avoid contact with eye

do not apply to wounds or damaged skin

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 Poison Control Center right away

Keep out of reach of children. If swallowed get medical help or contact a Poison Control center right away.

Topical Analgesic

Call 215.660.9123 or email us at info@elevatecbd.com

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

Children under 12 years of age

consult your physician

Keep out of direct sunlight

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

CBD

COOLING

THERAPY TOPICAL CREAM

Uses

for external use on muscles and joints where you feel stiffness

Keep out of reach of children

If swallowed get medical help or contact a Poison Control center right away

2 oz. cream heat tube

2 oz. cream Heating Therapy tube

ELEVATE HEATING THERAPY 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-458
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
CAPSICUM (UNII: 00UK7646FG)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
COCONUT OIL (UNII: Q9L0O73W7L)  
WHITE WAX (UNII: 7G1J5DA97F)  
SHEA BUTTER (UNII: K49155WL9Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
LAURETH-7 (UNII: Z95S6G8201)  
WITCH HAZEL (UNII: 101I4J0U34)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
CORN OIL (UNII: 8470G57WFM)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-458-0256 g in 1 TUBE; Type 0: Not a Combination Product11/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/04/2019
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-458)

Revised: 1/2022
Document Id: d57c85bc-4eb2-3fc9-e053-2a95a90a3917
Set id: 9ba4f8ff-5a95-2ea1-e053-2995a90acc77
Version: 3
Effective Time: 20220113
 
Renu Laboratories, Inc.