PAIN RELIEF Gel-Roll On

Manufacturer
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:24:38

Label at a glance#

ProductPAIN RELIEF Gel-Roll On
Active ingredientLIDOCAINE, MENTHOL
Label structure16 sections

Dosage and administration

Adults and children 12 over years : • apply a thin layer to affected area 6 to 8 hours, not to exceed 3 application in a 24 hour period Children under 12 years of age : Consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

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

Purpose

OTC - PURPOSE SECTION

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

Use

INDICATIONS & USAGE SECTION

temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

Ask a doctor if

OTC - ASK DOCTOR SECTION

• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

Flammable

OTHER SAFETY INFORMATION

• keep away from fire or flame

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 over years:

• apply a thin layer to affected area 6 to 8 hours, not to exceed 3 application in a 24 hour period

Children under 12 years of age: Consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments

OTC - QUESTIONS SECTION

86-21-31166566

GENERAL PRECAUTIONS SECTION

Child-resistant packaging. Close cap tightly after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container LabelContainer LabelPackage LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1804176lidocaine 4 % / menthol 1 % Topical GelPSN4
1804176lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD4
1804176lidocaine 4 % / menthol 1 % Topical GelSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73557-373-25PAIN RELIEF Gel-Roll On73 mL in 1 BOTTLEGEL734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73557-373PAIN RELIEF GEL-ROLL ON (LIDOCAINE AND MENTHOL) GEL [SHANGHAI CHUANGSHI MEDICAL TECHNOLOGY (GROUP) CO., LTD.]4Current NDC, Legacy NDC, 1 package rows20241013_f02fa9c0-b8af-f362-e053-2a95a90ae516.zip

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
73557-37373557-373-25

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 MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f02fa9c0-b8af-f362-e053-2a95a90ae5162024-10-11WarningsExact identifier
ndc (package): 73557-373-25
ndc (product): 73557-373
ndc11 (package): 73557037325
spl id: 243162c7-38ef-27db-e063-6294a90a9969
spl set id: f02fa9c0-b8af-f362-e053-2a95a90ae516

Reported adverse events (FAERS/openFDA)#

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