FDA.reportPublic FDA data

RUGBY LIDOCAINE

Manufacturer
Rugby Laboratories
Effective date
2025-09-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:28

Label at a glance#

ProductRUGBY LIDOCAINE
Active ingredientLIDOCAINE
Label structure11 sections

Dosage and administration

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor

Storage and handling

▪ store at 15 to 30°C (59 to 86°F) ▪ This package is child-resistant

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Not for prolonged use.

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • rash or irritation develops, persists, or increases

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 of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F)
  • This package is child-resistant

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
RUGBY® LABORATORIES
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

Maximum Strength
Lidocaine 4%
Pain and Itch Relief Cream

NDC 0536-1278-03

Compare to the active
ingredient in Gold Bond®
with 4% Lidocaine*

NET WT 0.52 OZ (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
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
0536-1278-03RUGBY LIDOCAINE1 in 1 CARTONCREAM14
0536-1278-03RUGBY LIDOCAINE15 g in 1 TUBECREAM154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1278-03GM - Gram0536-1278e4f14bcd-e011-427c-8f7e-745c3cc684dc12021-01-08

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12780536-1278-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARGININE94ZLA3W45FIACT
SULISOBENZONE1W6L629B4KIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
ANGOPHORA COSTATA WHOLEO5MY197D8FIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
STEARIC ACID4ELV7Z65APIACT
CAPRYLYL GLYCOL00YIU5438UIACT

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
d26a565f-3ba5-479c-b71f-bf4b191051d9836d7525-0e4a-430d-b86d-a6883f1dad632025-09-16WarningsExact identifier
spl id: d26a565f-3ba5-479c-b71f-bf4b191051d9
spl set id: 836d7525-0e4a-430d-b86d-a6883f1dad63

Reported adverse events (FAERS/openFDA)#

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