Indications and uses
For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.
FlexDermal Pain Relieving Roll-On Ointment
- Manufacturer
- SOLVADERM LLC
- Effective date
- 2025-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:54:40
Label at a glance#
ProductFlexDermal Pain Relieving Roll-On
Active ingredientMENTHOL
Label structure8 sections
Dosage and administration
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Menthol 2.00%
Purpose
Topical Analgesic
Uses
- For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.
Warnings
For external use only
Do not
- apply to wounds or damaged skin.
- bandage tightly.
When using this product
- Avoid contact with the eyes.
Stop use and ask a 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 a Poison Control Center right away.
If pregnant or breast-feeding,
ask a health professional before use
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: consult a doctor.
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1 (CI 42090), Camphor, Ethylhexylglycerin, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Sodium Hydroxide, Water(Aqua)
Questions?
888-211-8468
Package Labeling:
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84197-867-00 | FlexDermal Pain Relieving Roll-On | 90 mL in 1 BOTTLE | LIQUID | 90 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- FlexDermal Pain Relieving Roll-On
- MENTHOL
- FD&C BLUE NO. 1
- ETHYLHEXYLGLYCERIN
- GLYCERIN
- ISOPROPYL ALCOHOL
- PHENOXYETHANOL
- SODIUM HYDROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84197-867 | 84197-867-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
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 |
|---|---|---|---|---|---|---|
| FlexDermal Pain Relieving Roll-On | MENTHOL | SOLVADERM LLC | d4d8050e-0761-4491-8635-39c806701eb5 | 2025-02-06 | Warnings | 84197-867-00 84197-867 84197086700 2d76e34f-c583-4eae-e063-6294a90a5de5 d4d8050e-0761-4491-8635-39c806701eb5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.