Pain Relief Gel-Roll On

Manufacturer
Bullet point LLC | ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:56

Label at a glance#

ProductPain Relief Gel-Roll On
Active ingredientLIDOCAINE, MENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

OTC - PURPOSE SECTION

Purpose

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

WARNINGS SECTION

Warnings

For external use only

INDICATIONS & USAGE SECTION

Use

Temporary relief of pain

Do not use

• On large areas of the body or on cut, irritated, or swollen skin not apply to wounds or damaged skin • on puncture wounds • for more than one week without consulting a doctor.

When using this product

• Use only as directed. Read and follow all directions and warnings on this label

• Do not allow contact with eyes and mucous membranes

• Do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use

• Do not use at the same time as other topical analgesics

Stop use if

• Condition worsens

• Redness is present

• Irritation develops

• Symptoms persist for more than 7 days or clear up and occur within a few days

OTC - ASK DOCTOR SECTION

Ask a doctor if

• Condition worsens

• Redness is present

• Irritation develops

• Symptoms persist for more than 7 days or clear up and occur within a few days

WARNINGS AND PRECAUTIONS SECTION

Flammable

• Keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding

  • Ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and over:

  • Apply a thin layer to the affected area for 6 to 8 hours
  • Not to exceed 3 applications in a 24 hour period

Children under 12 years old: Consult a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Aloe Vera Extract, Carbomer, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

OTHER SAFETY INFORMATION

Child-resistant packaging. Close the cap tightly after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1804176lidocaine 4 % / menthol 1 % Topical GelPSN1
1804176lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD1
1804176lidocaine 4 % / menthol 1 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-135060643133300GTIN-13: 5060643133300
EAN-13: 5060643133300
GTIN storage (14 digits): 05060643133300
Principal Display Panel-Menthol Lidocaine.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84008-002-01Pain Relief Gel-Roll On73 mL in 1 BOTTLEGEL731
84008-002-02Pain Relief Gel-Roll On1 in 1 BOXGEL11

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
84008-00284008-002-01, 84008-002-02

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

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
Pain Relief Gel-Roll OnLIDOCAINE AND MENTHOLBullet point LLC42c70681-494b-47c9-e063-6394a90a80be2025-11-04WarningsExact identifier
ndc (package): 84008-002-02
ndc (package): 84008-002-01
ndc (product): 84008-002
ndc11 (package): 84008000201
ndc11 (package): 84008000202
spl id: 42c70b4f-638a-658c-e063-6294a90a0ea8
spl set id: 42c70681-494b-47c9-e063-6394a90a80be

Reported adverse events (FAERS/openFDA)#

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