FDA.reportPublic FDA data

PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)

Manufacturer
Guangzhou Zhupuyou E-commerce Co., Ltd | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:54

Label at a glance#

ProductPRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Temporary relieffrom minor aches and pains of sore muscles and joints associated with arthritisbackache, strains and sprains.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

do not apply to wounds or damaged skin
do not use with other ointments, creams, sprays,
or liniments.
do not apply to irritated skin
do not bandage or use with heating pad or device

OTC - WHEN USING SECTION

use only as directed
avoid contact with eyes or mucous membranes
wash hands after use with cool water
store in a cool dry place away from direct sunlight

OTC - STOP USE SECTION

You experience pain, swelling or blistering; condition worsens, or if symptoms persist for morethan 7 days,or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION


Adults and Children above 12 years old:Rub a thin film over affected areas not more 4times daily; massage not necessary
Children under age of 12: Consult a doctor

INACTIVE INGREDIENT SECTION

Alcohol
Aloe barbadensis leaf extract
Arnica montana flower extract
Boswellia carterii resin extract
Camellia sinensis leaf extract
Carbomer
Camphor
FD&C Blue 1
FD&C Yellow 5
Glycerin
Ilex Paraguariensis Leaf Extract
Isopropyl Myristate
Silica
Triethanolamine
Vitamin E
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN1
415974menthol 0.04 MG/MG Topical GelSCD1
415974menthol 4 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84165-013-01PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-01PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)1 in 1 BOXGEL11
84165-013-02PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)2 in 1 BOXGEL21
84165-013-02PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-03PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)3 in 1 BOXGEL31
84165-013-03PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-04PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-04PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)4 in 1 BOXGEL41
84165-013-05PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)5 in 1 BOXGEL51
84165-013-05PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-06PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-06PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)6 in 1 BOXGEL61
84165-013-07PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-07PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)7 in 1 BOXGEL71
84165-013-08PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)8 in 1 BOXGEL81
84165-013-08PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-09PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)9 in 1 BOXGEL91
84165-013-09PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-10PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-10PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)10 in 1 BOXGEL101

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
84165-01384165-013-01, 84165-013-02, 84165-013-03, 84165-013-04, 84165-013-05, 84165-013-06, 84165-013-07, 84165-013-08, 84165-013-09, 84165-013-10

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
ALCOHOL 95%7528N5H79BIACT
CARBOMER0A5MM307FCIACT
TRIETHANOLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
MENTHOLL7T10EIP3AACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
OLIBANUMR9XLF1R1WMIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SILICAETJ7Z6XBU4IACT

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
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd375bc794-3289-e610-e063-6294a90a4f9b2025-06-12WarningsExact identifier
ndc (package): 84165-013-06
ndc (package): 84165-013-09
ndc (package): 84165-013-04
ndc (package): 84165-013-07
ndc (package): 84165-013-03
ndc (package): 84165-013-10
ndc (package): 84165-013-05
ndc (package): 84165-013-08
ndc (package): 84165-013-01
ndc (package): 84165-013-02
ndc (product): 84165-013
ndc11 (package): 84165001309
ndc11 (package): 84165001301
ndc11 (package): 84165001303
ndc11 (package): 84165001304
ndc11 (package): 84165001307
ndc11 (package): 84165001308
ndc11 (package): 84165001305
ndc11 (package): 84165001310
ndc11 (package): 84165001302
ndc11 (package): 84165001306
spl id: 375bc794-328a-e610-e063-6294a90a4f9b
spl set id: 375bc794-3289-e610-e063-6294a90a4f9b

Reported adverse events (FAERS/openFDA)#

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