Freskaro Menthol 16% Roll-On
- Manufacturer
- Pharma Nobis, LLC
- Effective date
- 2026-04-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:53:42
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Menthol 16%
OTC - PURPOSE SECTION
Topical analgesic
INDICATIONS & USAGE SECTION
Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.
WARNINGS SECTION
For external use only.
Flammable
- Keep away from fire or flame.
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
- a temporary burning sensation may occur after use but normally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- if swelling or blistering of the skin occurs, stop use and seek medical attention
- do not expose treated area to heat or direct sunlight
Stop use and ask a doctor if
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding
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 or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily
IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.
Children 12 years or younger: do not use, ask a doctor
INACTIVE INGREDIENT SECTION
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine.
OTC - QUESTIONS SECTION
1-833-551-0932
2026 Label
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82645-014-97 | Hot/Cold Menthol 16% Roll-On | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 82645-014-97 | Hot/Cold Menthol 16% Roll-On | 74 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 74 | 1 |
Products#
Every source-derived product name is available through these pages.
- Hot/Cold Menthol 16% Roll-On
- (C10-C30)ALKYL METHACRYLATE ESTER
- PROPYLENE GLYCOL
- TROLAMINE
- ALCOHOL
- CAPSAICIN
- ISOPROPYL MYRISTATE
- GLYCERIN
- WATER
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82645-014 | 82645-014-97 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| (C10-C30)ALKYL METHACRYLATE ESTER | XH2FQZ38D8 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| CAPSAICIN | S07O44R1ZM | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Pharma Nobis, LLC | 4f6f5a0b-3bfa-289e-e063-6294a90a94b3 | 2026-04-14 | Warnings | 82645-014-97 82645-014 82645001497 4f6f50c3-79af-1aac-e063-6294a90a1a63 4f6f5a0b-3bfa-289e-e063-6294a90a94b3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

