Indications and uses
Aid for temporary local relief of minor pain in muscles or joints.
Tuvivex10
- Manufacturer
- Tuvive Therapeutics
- Effective date
- 2022-01-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:11:07
Label at a glance#
ProductTuvivex10
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections
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 place at 20 to 25 C (68 to77 F) with lid closed tightly.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
Menthol 4%
Purpose
Topical Analgesic
Uses
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
- 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
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
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
Store in a cool, dry place at 20 to 25 C (68 to77 F) with lid closed tightly.
Inactive Ingredients
Aqua, Emu Oil, Alcohol Denat., Stearic Acid, Glycerin, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Squalane, Stearyl Alcohol, Hemp-Derived Cannabidiol (CBD), Sodium Hydroxide, Aloe Barbadensis Leaf Extract, Boswellia Serrata Extract, Arnica Montana Flower 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 - 100 mL Bottle Label
Tuvīve
Therapeutics
73501-501-10
Tuvīvex™ 10
Menthol 4%
with premium CBD
and Emu Oil
Topical Pain
Cream
CBD
1000MG
Per Bottle
3.4 fl. oz (100 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73501-501-10 | 2025-01-07 | C162847 | 48780-1 | 1030e365-48a4-111a-e063-dadaa90a10e2 | Tuvīvex™10 |
| 73501-501-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-48a4-111a-e063-dadaa90a10e2 | Tuvīvex™10 |
Products#
Every source-derived product name is available through these pages.
- Tuvivex10
- MENTHOL, UNSPECIFIED FORM
- WATER
- Emu Oil
- ALCOHOL
- Stearic Acid
- Glycerin
- GLYCERYL MONOSTEARATE
- MEDIUM-CHAIN TRIGLYCERIDES
- Cetyl Alcohol
- Caprylyl Glycol
- Phenoxyethanol
- Hexylene Glycol
- Squalane
- Stearyl Alcohol
- CANNABIDIOL
- Sodium Hydroxide
- ALOE VERA LEAF
- INDIAN FRANKINCENSE
- ARNICA MONTANA FLOWER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73501-501 | 73501-501-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2b1f554b-f669-6cb1-e063-6294a90a7afe | 87396d87-c57d-44e2-a92c-66942430f047 | 2025-01-07 | Warnings | 87396d87-c57d-44e2-a92c-66942430f047 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.