FDA.reportPublic FDA data

KINETIC ICE Muscle and Joint Pain Relief Cream

Manufacturer
No Reason, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:06

Label at a glance#

ProductKINETIC ICE Muscle and Joint Pain Relief Cream
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

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. 

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgeic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

WARNINGS SECTION

For external use only.

Do not use:

OTC - DO NOT USE SECTION

on damaged or broken skin.

When Using This Product:

OTC - WHEN USING SECTION

Avoid contact with the eyes. Do not bandage tightly.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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:

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Glyceryl Stearate, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Polysorbate-20, Phenoxyethanol, Pyridoxine HCL (Vitamin B6), SD-Alcohol 40B, Stearic Acid, Triethanolamine.

Phone number:

SPL UNCLASSIFIED SECTION

+1(413) 422-3267

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleBoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253020menthol 10 % Topical CreamPSN2
253020menthol 100 MG/ML Topical CreamSCD2
253020menthol 10 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81050-108-00KINETIC ICE Muscle and Joint Pain Relief Cream118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81050-108KINETIC ICE MUSCLE AND JOINT PAIN RELIEF CREAM (MENTHOL) CREAM [NO REASON, LLC]2Current NDC, Legacy NDC, 1 package rows20231112_565f0e20-e534-41db-ba20-e726d578405f.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81050-10881050-108-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
ALCOHOL3K9958V90MIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
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
KINETIC ICE Muscle and Joint Pain Relief CreamMENTHOLNo Reason, LLC565f0e20-e534-41db-ba20-e726d578405f2023-11-11WarningsExact identifier
ndc (package): 81050-108-00
ndc (product): 81050-108
ndc11 (package): 81050010800
spl id: 09e2208a-9193-e219-e063-6394a90a7f63
spl set id: 565f0e20-e534-41db-ba20-e726d578405f

Reported adverse events (FAERS/openFDA)#

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