FDA.reportPublic FDA data

Kroger Cool and Heat Roll-On

Manufacturer
Kroger | Derma Care Research Labs, LLC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:58

Label at a glance#

ProductKroger Cool and Heat Roll-On
Active ingredientMENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

OTC - PURPOSE SECTION


External Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

WARNINGS SECTION

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years or older: clean affected area before applying product, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866084menthol 16 % Topical SolutionPSN1
866084menthol 160 MG/ML Topical SolutionSCD1
866084menthol 16 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011110082992GTIN-13: 0011110082992
EAN-13: 0011110082992
GTIN-12: 011110082992
UPC-A: 011110082992
GTIN storage (14 digits): 00011110082992		KRO-CHRLR-25_R1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-585-02Kroger Cool and Heat Roll-On1 in 1 CARTONLIQUID11
30142-585-02Kroger Cool and Heat Roll-On71 g in 1 BOTTLELIQUID711

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-58530142-585-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
XANTHAN GUMTTV12P4NEEIACT

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
Kroger Cool and Heat Roll-OnMENTHOLKroger46551d07-3006-c3ec-e063-6294a90aa3f22025-12-19WarningsExact identifier
ndc (package): 30142-585-02
ndc (product): 30142-585
ndc11 (package): 30142058502
spl id: 46551d07-3007-c3ec-e063-6294a90aa3f2
spl set id: 46551d07-3006-c3ec-e063-6294a90aa3f2

Reported adverse events (FAERS/openFDA)#

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