FDA.reportPublic FDA data

Rite Aid Lidocaine Roll on

Manufacturer
Velocity Pharma LLC
Effective date
2020-10-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:31:01

Label at a glance#

ProductRite Aid Lidocaine Roll on
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor 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
  • 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 carton.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to area of use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

  • 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 and pets.

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 over 12 years:

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

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera gel, cetyl alcohol, dimethicone, disodium EDTA, ethylhexylglycerin, C10-30 alkyl acrylate cross polymer, polysorbate 60, glycerin, triethanolamine, water, stearyl alcohol.

Child-resistant packaging. Close cap tightly after use. Keep carton as it contains important information.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11Pain-relieving-roll-on_2.5-flozPain-relieving-roll-on_2.5-floz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN3
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD3
1987647lidocaine hydrochloride 4 % Topical SolutionSY3

DailyMed Pharmacologic Classes#

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

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-307-472022-01-28C16284748780-1d6a99b39-c9f6-a426-e053-dadaa90af4c2Rite Aid Lidocaine Roll on 2.5oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-307-47Rite Aid Lidocaine Roll on1 in 1 CARTONLIQUID13
76168-307-47Rite Aid Lidocaine Roll on73 mL in 1 BOTTLE, WITH APPLICATORLIQUID733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-307RITE AID LIDOCAINE ROLL ON (LIDOCAINE HYDROCHLORIDE) LIQUID [VELOCITY PHARMA LLC]3Legacy NDC, 2 package rows20201006_6e53719e-db32-4776-9bc6-75ac793cf9e3.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76168-30776168-307-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
CETETH-20 PHOSPHATE921FTA1500IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
POLYSORBATE 60CAL22UVI4MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
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
b0ed6bd5-39fb-c3da-e053-2a95a90a07d36e53719e-db32-4776-9bc6-75ac793cf9e32020-10-05WarningsExact identifier
spl id: b0ed6bd5-39fb-c3da-e053-2a95a90a07d3
spl set id: 6e53719e-db32-4776-9bc6-75ac793cf9e3

Reported adverse events (FAERS/openFDA)#

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