FDA.reportPublic FDA data

Lidocaine Pain Relief Roll-On

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:39

Label at a glance#

ProductLidocaine Pain Relief Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

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, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

WARNINGS SECTION

For External Use Only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes

do not apply to wounds or damaged skin

do not use in large quantities

partifcularly over raw surfaces or blistered areas

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.

INDICATIONS & USAGE SECTION

For temporarily relief of pain and itching.

OTC - PURPOSE SECTION

Topical analgesic

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Lidocaine CartonCVS Lidocaine CartonCVGSLido.jpgCVGSLido.jpglidolido

Equate Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQLido.jpgEQLido.jpg

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
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9130-97Lidocaine Pain Relief Roll-On1 in 1 CARTONLIQUID14
0395-9130-97Lidocaine Pain Relief Roll-On74 mL in 1 BOTTLE, WITH APPLICATORLIQUID744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9130LIDOCAINE PAIN RELIEF ROLL-ON (LIDOCAINE 4%) LIQUID [HUMCO HOLDING GROUP, INC.]4Current NDC, Legacy NDC, 2 package rows20231216_a8be9e46-1616-40a9-e053-2a95a90ac3bc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91300395-9130-97

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
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
STEARETH-2153J3F32P58IACT
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
CETETH-20 PHOSPHATE921FTA1500IACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Humco Holding Group, Inc.a8be9e46-1616-40a9-e053-2a95a90ac3bc2023-12-15WarningsExact identifier
ndc (package): 0395-9130-97
ndc (product): 0395-9130
ndc11 (package): 00395913097
spl id: 0c9380d5-c285-0902-e063-6394a90ac157
spl set id: a8be9e46-1616-40a9-e053-2a95a90ac3bc

Reported adverse events (FAERS/openFDA)#

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