Rugby Lidocaine Cream

Manufacturer
Rugby Laboratories
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:46

Label at a glance#

ProductRugby Lidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Cetostearyl Alcohol, Citric Acid, Edetate Disodium, Light Mineral Oil, Methylparaben, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, White Petrolatum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN2
1421893lidocaine 40 MG/ML Topical CreamSCD2
1421893lidocaine 4 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1357-95Rugby Lidocaine1 in 1 BOXCREAM12
0536-1357-95Rugby Lidocaine28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1357RUGBY LIDOCAINE (LIDOCAINE 4%) CREAM [RUGBY LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20241217_d94292f7-10fc-48bf-e053-2995a90a8472.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1357-95GM - Gram0536-1357b2ee3ee6-3878-4dd0-8240-713d832e329e12022-05-04

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13570536-1357-95

Ingredients#

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

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

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
Rugby LidocaineLIDOCAINE 4%Rugby Laboratoriesd94292f7-10fc-48bf-e053-2995a90a84722024-12-15WarningsExact identifier
ndc (package): 0536-1357-95
ndc (product): 0536-1357
ndc11 (package): 00536135795
spl id: 2956c188-f287-a837-e063-6394a90a0470
spl set id: d94292f7-10fc-48bf-e053-2995a90a8472

Reported adverse events (FAERS/openFDA)#

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