FDA.reportPublic FDA data

elevate HEATING THERAPY TOPICAL CREAM

Manufacturer
Renu Laboratories, Inc.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:42

Label at a glance#

Productelevate HEATING THERAPY
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

for external use on muscles and joints where you feel stiffness

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5 percent

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Topical Analgesic

OTC - QUESTIONS SECTION

Call 215.660.9123 or email us at info@elevatecbd.com

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Keep out of direct sunlight

INACTIVE INGREDIENT SECTION

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

STATEMENT OF IDENTITY SECTION

elevate

CBD

COOLING

THERAPY TOPICAL CREAM

Uses

INDICATIONS & USAGE SECTION

for external use on muscles and joints where you feel stiffness

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 oz. cream heat tube2 oz. cream heat tube

2 oz. cream Heating Therapy tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1114454menthol 0.5 % Topical CreamPSN3
1114454menthol 5 MG/ML Topical CreamSCD3
1114454menthol 0.5 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-458-022025-01-30C16284748780-12cef2736-8472-d83d-e063-dadaa90ab31felevate HEATING THERAPY TOPICAL CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-458-02elevate HEATING THERAPY56 g in 1 TUBECREAM563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-458ELEVATE HEATING THERAPY (MENTHOL) CREAM [RENU LABORATORIES, INC.]3Legacy NDC, 1 package rows20220114_9ba4f8ff-5a95-2ea1-e053-2995a90acc77.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-45876348-458-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSICUM00UK7646FGIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
COCONUT OILQ9L0O73W7LIACT
WHITE WAX7G1J5DA97FIACT
SHEA BUTTERK49155WL9YIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
OLIVE OIL6UYK2W1W1EIACT
STEARIC ACID4ELV7Z65APIACT
GRAPEFRUIT OILYR377U58W9IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
LAURETH-7Z95S6G8201IACT
WITCH HAZEL101I4J0U34IACT
MENTHOLL7T10EIP3AACTIB
CANNABIDIOL19GBJ60SN5IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 4500TVH7653921IACT
CORN OIL8470G57WFMIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d57c85bc-4eb2-3fc9-e053-2a95a90a39179ba4f8ff-5a95-2ea1-e053-2995a90acc772022-01-13WarningsExact identifier
spl id: d57c85bc-4eb2-3fc9-e053-2a95a90a3917
spl set id: 9ba4f8ff-5a95-2ea1-e053-2995a90acc77

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.