FDA.reportPublic FDA data

Elevate Heating 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 23:46:41

Label at a glance#

ProductElevate Heating Therapy TWIST UP
Active ingredientMENTHOL
Label structure13 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 5%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

  • For external use only
  • 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

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.

Directions

INSTRUCTIONS FOR USE 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.

Other information

OTHER SAFETY INFORMATION

  • Keep out of direct sunlight.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract, Capsicum Frutescens (Pepper) Fruit 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

OTC - QUESTIONS SECTION

Questions? 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 as directed by your doctor

RECENT MAJOR CHANGES SECTION

Dosage and Administration section did not exist prior to 01-06-2020. It was missed and created today.

Bullet mark only was removed.

Removed the word "Directions."

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2oz-stick2oz-stick

Elevate 2oz Cream Stick

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
76348-454-012025-01-30C16284748780-12cef2736-8d75-d83d-e063-dadaa90ab31fELEVATE HEATING THERAPY TWIST UP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-454-01Elevate Heating Therapy TWIST UP56 g in 1 APPLICATORCREAM562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-454ELEVATE HEATING THERAPY TWIST UP (MENTHOL CREAM) CREAM [RENU LABORATORIES, INC.]2Legacy NDC, 1 package rows20220114_99d90b4d-c6f1-8b23-e053-2a95a90a6843.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
76348-45476348-454-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
CANNABIDIOL19GBJ60SN5IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-7Z95S6G8201IACT
WITCH HAZEL101I4J0U34IACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
OLIVE OIL6UYK2W1W1EIACT
CORN OIL8470G57WFMIACT
COCONUT OILQ9L0O73W7LIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
PEG-100 STEARATEYD01N1999RIACT
PEPPERMINT OILAV092KU4JHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
TABASCO PEPPERJ1M3NA843LIACT
WHITE WAX7G1J5DA97FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT

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
d57c916b-de5f-93c6-e053-2a95a90a380c99d90b4d-c6f1-8b23-e053-2a95a90a68432022-01-13WarningsExact identifier
spl id: d57c916b-de5f-93c6-e053-2a95a90a380c
spl set id: 99d90b4d-c6f1-8b23-e053-2a95a90a6843

Reported adverse events (FAERS/openFDA)#

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