FDA.reportPublic FDA data

elevate COOLING THERAPY TWIST UP

Manufacturer
Renu Laboratories, Inc.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:42

Label at a glance#

Productelevate COOLING THERAPY TWIST UP
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol

OTC - STOP USE SECTION

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.

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

Purpose

Topical Analgesic

OTC - QUESTIONS SECTION

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

OTC - WHEN USING SECTION

When using this product

  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use with heating pads or other heating devices.

OTHER SAFETY INFORMATION

Other information

  • Keep out of direct sunlight

STATEMENT OF IDENTITY SECTION

elevate CBD COOLING THERAPY TWIST UP TOPICAL with Menthol

INDICATIONS & USAGE SECTION

Uses

  • For external use on muscles and joints where you feel soreness

DOSAGE & ADMINISTRATION SECTION

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.

RECENT MAJOR CHANGES SECTION

Bullets removed

The word "Directions" was removed

WARNINGS SECTION

Warnings

  • For external use only
  • When using this product do not bandage tightly
  • avoid contact with eyes
  • do not apply to to wounds or damaged skin
  • do not use with heating pads or other heating devices

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

elevate Twist Up Topical label

2oz stick label2oz stick label

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
76348-456-012025-01-30C16284748780-12cef2736-63e9-d83d-e063-dadaa90ab31felevate COOLING THERAPY TWIST UP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-456-01elevate COOLING THERAPY TWIST UP56 g in 1 APPLICATORCREAM562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-456ELEVATE COOLING THERAPY TWIST UP (MENTHOL) CREAM [RENU LABORATORIES, INC.]2Legacy NDC, 1 package rows20220114_9a13830b-b8b0-276e-e053-2995a90a3573.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-45676348-456-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
WITCH HAZEL101I4J0U34IACT
SHEA BUTTERK49155WL9YIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CANNABIDIOL19GBJ60SN5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
OLIVE OIL6UYK2W1W1EIACT
COCONUT OILQ9L0O73W7LIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
MENTHOLL7T10EIP3AACTIB
CETEARYL GLUCOSIDE09FUA47KNAIACT
WATER059QF0KO0RIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
STEARIC ACID4ELV7Z65APIACT
WHITE WAX7G1J5DA97FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
CORN OIL8470G57WFMIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT

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-4eb0-3fc9-e053-2a95a90a39179a13830b-b8b0-276e-e053-2995a90a35732022-01-13WarningsExact identifier
spl id: d57c85bc-4eb0-3fc9-e053-2a95a90a3917
spl set id: 9a13830b-b8b0-276e-e053-2995a90a3573

Reported adverse events (FAERS/openFDA)#

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