FDA.reportPublic FDA data

K2 Cold Therapy

Manufacturer
The Podiatree Co
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:05

Label at a glance#

ProductK2 Cold Therapy
Active ingredientMENTHOL
Label structure13 sections

Indications and uses

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH: ARTHRITIS SIMPLE BACKACHE MUSCLE STRAINS SPRAINS

Dosage and administration

Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily. Children 12 years of age or younger: Consult a doctor. Close cap tightly after use.

Storage and handling

Store at controlled room temperature. Do not shake bottle with cap removed.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

  • ARTHRITIS
  • SIMPLE BACKACHE
  • MUSCLE STRAINS
  • SPRAINS

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Do not bandage tighlty or use with a heating pad
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged, broken, or irritated skin.

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 reoccur within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily.
  • Children 12 years of age or younger: Consult a doctor.
  • Close cap tightly after use.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature. Do not shake bottle with cap removed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)

Questions or Suggestions?

OTC - QUESTIONS SECTION

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisf ication. If you are not completely satisfied, please contact us for a full refund.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259249menthol 10 % Topical GelPSN4
259249menthol 0.1 MG/MG Topical GelSCD4
259249menthol 10 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-414-03K2 Cold Therapy88.72 mL in 1 BOTTLE, WITH APPLICATORLIQUID88.724

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54633-41454633-414-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
POLYSORBATE 806OZP39ZG8HIACT
ROSMARINUS OFFICINALIS WHOLEEA3289138MIACT
ALCOHOL3K9958V90MIACT
SIMMONDSIA CHINENSIS WHOLEDFM16KFA82IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
UREA8W8T17847WIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
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
K2 Cold TherapyMENTHOLThe Podiatree Co60dce1ad-125e-396d-e053-2a91aa0a670f2026-01-08WarningsExact identifier
ndc (package): 54633-414-03
ndc (product): 54633-414
ndc11 (package): 54633041403
spl id: 47e35d17-8734-e55a-e063-6294a90a82ee
spl set id: 60dce1ad-125e-396d-e053-2a91aa0a670f

Reported adverse events (FAERS/openFDA)#

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