FDA.reportPublic FDA data

Rugby Lidocaine

Manufacturer
Rugby Laboratories
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:40:40

Label at a glance#

ProductRugby Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adults and children over 12 years:  apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period Children under 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

Uses

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 consultanting 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 notallow contact with the eyes

do not bandage or apply local heat (such as heating pads) to the area of use.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptons persist for more than 7 days or clear up and occur again within a few days.
  • If pregnant or breast feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 12 years: 
  • apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period
  • Children under 12 years  or younger:ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

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, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)

Principal Panel-Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY® NDC 0536-1139-20

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 15g (0.52 oz)

RugbyLido4Tube15gRugbyLido4Tube15g

Principal Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY® NDC 0536-1139-20

Maxium Strength

4% Lidocaine

Pain Relieving Cream

NET WT. 15g (0.52 oz)

RugbyLido4Box15gRugbyLido4Box15g

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1139-20GM - Gram0536-1139610ea334-9825-47fb-9397-59074b52867612018-11-06
0536-1139-28GM - Gram0536-1139f52a61da-fc4d-48f5-95a0-40368ddc59d312019-05-02

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
0536-11390536-1139-20, 0536-1139-28

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
WATER059QF0KO0RIACT
SILICONZ4152N8IUIIACT
ALCOHOL3K9958V90MIACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
DIMETHICONE 3502Y53S6ATLUIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARETH-2153J3F32P58IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETEARETH-2 PHOSPHATE8NSU66JGZRIACT
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
4e55aa90-d79b-b849-e063-6294a90a52ac56b4b8e9-ab92-4635-b9ec-aa6f5390101f2026-03-31WarningsExact identifier
spl set id: 56b4b8e9-ab92-4635-b9ec-aa6f5390101f

Reported adverse events (FAERS/openFDA)#

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