FDA.reportPublic FDA data

RR Roll-On for Pain

Manufacturer
Revolutionary Relief dba Medical XLabs
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:14

Label at a glance#

ProductRR Roll-On for Pain
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves pain and itching

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching

Warnings

WARNINGS SECTION

  • For external use only Use only as direacted
  • Do not allow contact with the eyes and mucuous membrances.
  • Do not apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics 
  • Stop use and ask a doctor if: allergic reaction occurs 
  • condition worsen or does not improve within 7 days 
  • redness, irritation, swelling, pain or other symptoms begin or increase.
  • If pregnant or Breastfeeding 

   Ask a health professional before use.

Keep out of reach of children 

  If swallowed, get medical help or Contact a Posion Control right away. Emergency number : 1-800-222-1222

Direaction

DOSAGE & ADMINISTRATION SECTION

    Adults and children 12 years of age or older:

  • Apply to affected area not more than 3 to 4 times daily
  • Children under two years of age, consult a physicion

Additional information

SPL UNCLASSIFIED SECTION

Store in a cool, dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Alcohol Denat., Butylene Glycol, Steareth-21, Steareth-2, Cetyl Alcohol, Hemp Seed Oil, Glycerin, Caprylyl Glycol, Kannopia-Active TM Proprietary Hemp Extract, Tocopherol, Arnica Montana Flower Extract, Boswellia Serrata (Frankincense) Extract, Plantago Major (Plantain) Leaf
Extract, Phenoxyethanol, Hexelene Glycol, Xanthan Gum, Hexyl Cinnamic Aldehyde, Coumarin, Limonene, Peppermint

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83048-001-01RR Roll-On for Pain60 mL in 1 BOTTLE, DISPENSINGGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83048-001RR ROLL-ON FOR PAIN (LIDOCAINE HCL) GEL [REVOLUTIONARY RELIEF DBA MEDICAL XLABS]3Legacy NDC, 1 package rows20241205_26ce6127-c90e-4c96-85b9-1a4560c5f144.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83048-00183048-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEARETH-2153J3F32P58IACT
STEARETH-2V56DFE46J5IACT
CETYL ALCOHOL936JST6JCNIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEMPTD1MUT01Q7IACT
TOCOPHEROLR0ZB2556P8IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
COUMARINA4VZ22K1WTIACT
LIMONENE, (+)-GFD7C86Q1WIACT
PEPPERMINTV95R5KMY2BIACT
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
27d4f30f-0d70-5e05-e063-6394a90a534e26ce6127-c90e-4c96-85b9-1a4560c5f1442024-11-26WarningsExact identifier
spl id: 27d4f30f-0d70-5e05-e063-6394a90a534e
spl set id: 26ce6127-c90e-4c96-85b9-1a4560c5f144

Reported adverse events (FAERS/openFDA)#

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