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#

ProductHot/Cold Menthol 16% Roll-On
Active ingredientMENTHOL
Label structure11 sections

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

OTC - STOP USE SECTION

  • 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

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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Menthol Carton 2026Freskaro Menthol Carton 2026Freskaro Menthol Bottle 2026Freskaro Menthol Bottle 2026

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-014-97Hot/Cold Menthol 16% Roll-On1 in 1 CARTONLIQUID11
82645-014-97Hot/Cold Menthol 16% Roll-On74 mL in 1 BOTTLE, WITH APPLICATORLIQUID741

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82645-01482645-014-97

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONPharma Nobis, LLC4f6f5a0b-3bfa-289e-e063-6294a90a94b32026-04-14WarningsExact identifier
ndc (package): 82645-014-97
ndc (product): 82645-014
ndc11 (package): 82645001497
spl id: 4f6f50c3-79af-1aac-e063-6294a90a1a63
spl set id: 4f6f5a0b-3bfa-289e-e063-6294a90a94b3

Reported adverse events (FAERS/openFDA)#

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