Tuvivex

Manufacturer
Tuvive Therapeutics
Effective date
2022-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:10:58

Label at a glance#

ProductTuvivex
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Aid for temporary local relief of minor pain in muscles or joints.

Dosage and administration

Adults and children two years of age or older: Apply to affected area not more than three to four times daily. Children under two years of age, consult a physician.

Storage and handling

Store in a cool, dry ptace at 20 to 25 C (68 to77 F) with lid closed tightly.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Aid for temporary local relief of minor pain in muscles or joints.

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • Do not apply to wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult a physician.

IF PREGNANT OR BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children two years of age or older:

  • Apply to affected area not more than three to four times daily.
  • Children under two years of age, consult a physician.

Additional Information

STORAGE AND HANDLING SECTION

Store in a cool, dry ptace at 20 to 25 C (68 to77 F) with lid closed tightly.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Alcohol Denat, Steareth-21, Glycerin, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Hemp-Derived Cannabidiol (CBD), Arnica Montana Flower Extract, Steareth-2, Cetyl Alcohol, Xanthan Gum, Boswellia Serrata Extract.

OTC - QUESTIONS SECTION

To report a serious adverse event or to obtain product information, contact Company number at 1-844-720-7251

PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tuvīve
Therapeutics

73501-500-90

Tuvīvex™
Menthol 4% Roll on Gel
with CBD

Roll On
Pain Gel

CBD
500MG
Per Bottle

3 fl. oz (90 mL)

PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73501-500-902025-01-07C16284748780-11030e365-0d50-111a-e063-dadaa90a10e2Tuvīvex™
73501-500-902024-01-30C16284748780-11030e365-0d50-111a-e063-dadaa90a10e2Tuvīvex™

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73501-50073501-500-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
2b1ebd39-88d7-c5a3-e063-6394a90a8a613b1f601d-58df-4429-b65e-bbc52d4711c32025-01-07WarningsExact identifier
spl set id: 3b1f601d-58df-4429-b65e-bbc52d4711c3

Reported adverse events (FAERS/openFDA)#

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