Cold Therapy Pain Relief Roll-On

Manufacturer
Meijer | Product Quest Mfg
Effective date
2018-07-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:16

Label at a glance#

ProductCold Therapy Pain Relief Roll-On Meijer
Active ingredientMenthol
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                   Purpose
Menthol 4%..........................................................Topical Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
For external use only.
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 or if excessive irritation develops • do not
bandage • 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 occur again within a
few days.
If pregnant or breastfeeding ask a health professional before use

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 12 years of age and older: Apply on to the
affected areas not more than 3-4 times daily.
• Children under 12 years of age: Consult physician

OTHER SAFETY INFORMATION

Other information
Store in a cool dry place with lid closed tightly

INACTIVE INGREDIENT SECTION

Inactive ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock)
Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin
Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract,
Camphor, Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Ilex
Paraguariensis (Mate) Leaf Extract, Isopropyl Alcohol, Isopropyl
Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica,
Tocopheryl Acetate, Triethanolamine, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-788-032020-01-31C16284748780-19d75b9cf-df01-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-788-03Cold Therapy Pain Relief Roll-OnMeijer85 g in 1 TUBEGEL852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-788COLD THERAPY PAIN RELIEF ROLL-ON MEIJER (MENTHOL 4%) GEL [MEIJER]2Legacy NDC, 1 package rows20180712_de712d51-d2f8-4a31-b0a6-e6c8f599946b.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-78841250-788-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
af21fa15-71ed-4744-b84c-b678caa4d3fede712d51-d2f8-4a31-b0a6-e6c8f599946b2018-07-11WarningsExact identifier
spl id: af21fa15-71ed-4744-b84c-b678caa4d3fe
spl set id: de712d51-d2f8-4a31-b0a6-e6c8f599946b

Reported adverse events (FAERS/openFDA)#

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