FDA.reportPublic FDA data

Rite Aid Pain Relieving Roll-On

Manufacturer
Rite Aid Corporation | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2024-08-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:17

Label at a glance#

ProductRite Aid Pain Relieving Roll-On
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Directions 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#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warning

WARNINGS SECTION

For External use only

OTC - DO NOT USE SECTION

Do not use■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

OTC - WHEN USING SECTION

When using this product

■use only as directed. Read and follow all directions and warnings on this carton

■ do not allow contact with the eyes and mucous membranes

■do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

■do not use at the same time as other topical analgesics

OTC - STOP USE SECTION

Stop use and ask a doctor if

■condition worsens ■ redness is present
■irritation develops

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

OTHER SAFETY INFORMATION

Flammable

Keep away from fire or flame

Store at room temperature

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 if reach of children and pets

If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
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 INGREDIENT SECTION

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, amynomethylpropanol, cetelh-10 phosphate, cetostearyl alcohol, cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone
crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 MPA.S at 1.5%), sohexadecane, phenoxyethanol, SD alcohol, steareth-21, water

OTC - QUESTIONS SECTION

Call 1-866-326-1313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
11822-9989-1Rite Aid Pain Relieving Roll-On73 mL in 1 BOTTLELIQUID732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-9989RITE AID PAIN RELIEVING ROLL-ON (LIDOCAINE HCL) LIQUID [RITE AID CORPORATION]2Current NDC, 1 package rows20240817_1406590c-667c-84eb-e063-6294a90a5052.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
11822-998911822-9989-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
ISOHEXADECANE918X1OUF1EIACT
STEARETH-2153J3F32P58IACT
GLYCERYL 1-STEARATE258491E1RZIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONE 3502Y53S6ATLUIACT
ALCOHOL3K9958V90MIACT

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
Rite Aid Pain Relieving Roll-OnLIDOCAINE HCLRite Aid Corporation1406590c-667c-84eb-e063-6294a90a50522024-08-16WarningsExact identifier
ndc (package): 11822-9989-1
ndc (product): 11822-9989
ndc11 (package): 11822998901
spl id: 1fcd7134-c44b-1b6a-e063-6394a90ad80e
spl set id: 1406590c-667c-84eb-e063-6294a90a5052

Reported adverse events (FAERS/openFDA)#

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