Cold Therapy Pain Relief

Manufacturer
Kroger | Product Quest Mfg.
Effective date
2018-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:15

Label at a glance#

ProductCold Therapy Pain Relief
Active ingredientMenthol
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                            Purpose
Menthol 10.5%..............................................................Topical Analgesic

INDICATIONS & USAGE SECTION

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

WARNINGS SECTION

Warnings
For external use only.
Flammable: Do not use while smoking or near heat or flame.
When using this product • avoid contact with the eyes or mucous
membranes • do not apply to wounds or damaged skin • do not apply
to the irritated skin • do not bandage • wash hands after use with cool
water • do not use with heating pad or device
Stop use and ask a doctor if • condition worsens, or if symptoms
persist for more than 7 days, or clear up and reoccur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally ingested get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Directions • 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 physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients Alcohol Denat., Arnica Montana Flower
Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf
Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone, Echinacea
Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate,
Juniperus Communis Fruit Extract, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489073menthol 10.5 % Topical SprayPSN1
1489073menthol 105 MG/ML Topical SpraySCD1
1489073menthol 10.5 % Topical SpraySY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041260384721GTIN-13: 0041260384721
EAN-13: 0041260384721
GTIN-12: 041260384721
UPC-A: 041260384721
GTIN storage (14 digits): 00041260384721
label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59450-777-032020-01-31C16284748780-19d75b9d1-1260-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-777-03Cold Therapy Pain Relief85 g in 1 CANSPRAY851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-777COLD THERAPY PAIN RELIEF (MENTHOL 10.5%) SPRAY [KROGER]1Legacy NDC, 1 package rows20180712_1b98a3dc-1999-4db1-86e4-b0ab7d9ce808.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59450-77759450-777-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

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
ebad0ba6-dd40-4347-ad06-29e9381d05261b98a3dc-1999-4db1-86e4-b0ab7d9ce8082018-07-12WarningsExact identifier
spl id: ebad0ba6-dd40-4347-ad06-29e9381d0526
spl set id: 1b98a3dc-1999-4db1-86e4-b0ab7d9ce808

Reported adverse events (FAERS/openFDA)#

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