FDA.reportPublic FDA data

Hot/Cold Menthol 16% Roll-On

Manufacturer
Humco Holding Group, Inc | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:39

Label at a glance#

ProductHot/Cold Menthol 16% Roll-On
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

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.

WARNINGS SECTION

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. If you experience pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek professional attention immediately. These products produce local warmth or coolness.

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%Z), Triethanolamine, Purified Water.

INDICATIONS & USAGE SECTION

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

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.

OTC - PURPOSE SECTION

Topical analgesic

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Equate Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

painpain

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
0395-9131-97Hot/Cold Menthol 16% Roll-On74 mL in 1 CONTAINERLIQUID743

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9131HOT/COLD MENTHOL 16% ROLL-ON LIQUID [HUMCO HOLDING GROUP, INC]3Current NDC, Legacy NDC, 1 package rows20231216_a8bf9744-9979-13c1-e053-2a95a90a30aa.zip

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
0395-91310395-9131-97

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MIACT
CAPSAICINS07O44R1ZMIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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-ONHumco Holding Group, Inca8bf9744-9979-13c1-e053-2a95a90a30aa2023-12-15WarningsExact identifier
ndc (package): 0395-9131-97
ndc (product): 0395-9131
ndc11 (package): 00395913197
spl id: 0c93883b-eed9-0f96-e063-6394a90ae9aa
spl set id: a8bf9744-9979-13c1-e053-2a95a90a30aa

Reported adverse events (FAERS/openFDA)#

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