LIDOCAINE

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2023-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:53:31

Label at a glance#

ProductLIDOCAINE
Active ingredientLIDOCAINE
Label structure20 sections

Indications and uses

Uses: Temporaily relieves minor pains.

Dosage and administration

Directions Adults and children over 12 years: ■ clean and dry affected area ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected ar...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

OTC - PURPOSE SECTION

Temporarily relieves minor pain.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children over 12 years:

■ clean and dry affected area

■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area

■ use one patch for up to 12 hours. Children under 12 years of age: consult a physician.

Warnings

WARNINGS SECTION

For external use only

Indications and Usage

INDICATIONS & USAGE SECTION

Uses: Temporaily relieves minor pains.

When using this product

OTC - WHEN USING SECTION

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

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

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

■ do not microwave

■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor

OTC - STOP USE SECTION

■ condition worsens

■ redness is present

■ irritation develops

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

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

Do not Use

OTC - DO NOT USE SECTION

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,
Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

OTC - QUESTIONS SECTION

TOLL-FREE

Customer Care Help Line
866-445-2158

DISTRIBUTED BY RUGBY HEALTH
Livonia, MI 48152


Made in China

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

When using this product

OTC - WHEN USING SECTION

use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

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

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

■ do not microwave

■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor

OTC - STOP USE SECTION

  • condition worsens

■ redness is present

■ irritation develops

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

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over:

■ clean and dry affected area

■ carefully remove backing from patch starting at a corner

■ apply sticky side of patch to affected area

■ use one patch for up to 12 hours.

  • Discard patch after single use
  • Children under 12 years of age: consult a physician.

Other safety information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,

Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2925-52025-01-30C16284748780-12cef2736-5e07-d83d-e063-dadaa90ab31fRugby PAIN RELIEF PATCHES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2925-5LIDOCAINE5 in 1 CARTONPATCH51
68071-2925-5LIDOCAINE9 g in 1 PATCHPATCH91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2925LIDOCAINE PATCH [NUCARE PHARMACEUTICALS,INC.]12 package rows20230127_f3328300-1887-05db-e053-2995a90afc31.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1202-07EA - Each0536-120211ae0ca7-1ae4-4de5-8e90-c2d8b6315bfd12021-12-08
0536-1202-15EA - Each0536-1202c3078b81-c0ac-472e-9f94-ce67f88193f712019-10-07
0536-1202-29EA - Each0536-1202b9b515f0-6121-4a45-8f1c-94db558d724212025-06-13

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
68071-292568071-2925-5
0536-1202

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsExact identifier
ndc (product): 0536-1202
f332a521-225c-20a9-e053-2a95a90adaf1f3328300-1887-05db-e053-2995a90afc312023-01-26WarningsExact identifier
spl id: f332a521-225c-20a9-e053-2a95a90adaf1
spl set id: f3328300-1887-05db-e053-2995a90afc31

Reported adverse events (FAERS/openFDA)#

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