FDA.reportPublic FDA data

HEEL PAIN Relief Gel Roll-On

Manufacturer
Guangzhou Zhupuyou E-commerce Co., Ltd | Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:12

Label at a glance#

ProductHEEL PAIN Relief Gel Roll-On
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 relief from minor aches and pains ofsore muscles and joints associated with arthritis,backache, 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 skinwash hands after use with cool water
do not bandage or use with heating pad ordevice

OTC - WHEN USING SECTION

use only as directed
avoid contact with eyes or mucous membranes
store in a cool dry place away from directsunlight

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 afew days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION


Adults and Children above 12 years old:
Rub a thin film over affected areas not more 4 times 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

label2label2

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
84165-011-01HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-01HEEL PAIN Relief Gel Roll-On1 in 1 BOXGEL11
84165-011-02HEEL PAIN Relief Gel Roll-On2 in 1 BOXGEL21
84165-011-02HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-03HEEL PAIN Relief Gel Roll-On3 in 1 BOXGEL31
84165-011-03HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-04HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-04HEEL PAIN Relief Gel Roll-On4 in 1 BOXGEL41
84165-011-05HEEL PAIN Relief Gel Roll-On5 in 1 BOXGEL51
84165-011-05HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-06HEEL PAIN Relief Gel Roll-On6 in 1 BOXGEL61
84165-011-06HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-07HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-07HEEL PAIN Relief Gel Roll-On7 in 1 BOXGEL71
84165-011-08HEEL PAIN Relief Gel Roll-On8 in 1 BOXGEL81
84165-011-08HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-09HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-09HEEL PAIN Relief Gel Roll-On9 in 1 BOXGEL91
84165-011-10HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-10HEEL PAIN Relief Gel Roll-On10 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
84165-01184165-011-01, 84165-011-02, 84165-011-03, 84165-011-04, 84165-011-05, 84165-011-06, 84165-011-07, 84165-011-08, 84165-011-09, 84165-011-10

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

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
HEEL PAIN Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36bacb5f-c1af-2e97-e063-6394a90afe5c2025-06-04WarningsExact identifier
ndc (package): 84165-011-08
ndc (package): 84165-011-06
ndc (package): 84165-011-01
ndc (package): 84165-011-10
ndc (package): 84165-011-05
ndc (package): 84165-011-07
ndc (package): 84165-011-04
ndc (package): 84165-011-03
ndc (package): 84165-011-02
ndc (package): 84165-011-09
ndc (product): 84165-011
ndc11 (package): 84165001106
ndc11 (package): 84165001102
ndc11 (package): 84165001107
ndc11 (package): 84165001101
ndc11 (package): 84165001110
ndc11 (package): 84165001105
ndc11 (package): 84165001104
ndc11 (package): 84165001103
ndc11 (package): 84165001108
ndc11 (package): 84165001109
spl id: 36bacb5f-c1b0-2e97-e063-6394a90afe5c
spl set id: 36bacb5f-c1af-2e97-e063-6394a90afe5c

Reported adverse events (FAERS/openFDA)#

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