FDA.reportPublic FDA data

Pain Relief Roll-on

Manufacturer
Product Quest Mfg
Effective date
2018-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:26

Label at a glance#

ProductPain Relief Roll-on
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                              Purpose
Lidocaine HCl 4%..............................................Topical anesthetic

INDICATIONS & USAGE SECTION

Uses For temporary relief of pain and itching

WARNINGS SECTION

Warnings
For external use only.
When using this product • use only as directed • avoid contact with eyes • do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis
Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl
Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol,
Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium
EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD
Alcohol 40, Steareth-21, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN1
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD1
1010077lidocaine hydrochloride 4 % Topical GelSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64048-3333-32020-01-31C16284748780-19d75b9cf-ce24-f424-e053-dadaa90a57ceScherer Labs Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64048-3333-3Pain Relief Roll-on74 mL in 1 CONTAINERGEL741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64048-3333PAIN RELIEF ROLL-ON (LIDOCAINE HCL) GEL [PRODUCT QUEST MFG]1Legacy NDC, 1 package rows20180504_d496ad27-2d2e-4deb-b005-f023668ad486.zip

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
64048-333364048-3333-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Ceteth-20 Phosphate921FTA1500IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
Dimethicone92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
Ethylhexylglycerin147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MethylparabenA2I8C7HI9TIACT
ALCOHOL3K9958V90MIACT
Steareth-2153J3F32P58IACT
WATER059QF0KO0RIACT

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
8b695c0a-f522-4ed4-b654-5cfe76163f6ed496ad27-2d2e-4deb-b005-f023668ad4862018-05-03WarningsExact identifier
spl id: 8b695c0a-f522-4ed4-b654-5cfe76163f6e
spl set id: d496ad27-2d2e-4deb-b005-f023668ad486

Reported adverse events (FAERS/openFDA)#

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