Niravi 24 Hours Lidocaine 4 % Patch

Manufacturer
Sparsha Pharma USA, Inc.
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:53:29

Label at a glance#

ProductNiravi 24 Hours Lidocaine 4 % Patch
Active ingredientLIDOCAINE
Label structure14 sections

Dosage and administration

Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Do not expose area to heat. Children under 12 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor pain.

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

• If you are allergic to any active or inactive ingredients of this product
• On wounds or damaged, irritated or sensitive skin
• With any other topical anesthetic
• For more than one week without consulting a doctor
• With a heating pad
• If pouch is damaged or opened.

When using this product

OTC - WHEN USING SECTION

• Do not allow contact with the eyes
• Use only as directed
• Read and follow all directions and warnings on this package
• Do not bandage tightly or apply local heat to the area of use
• Do not reuse patch
• Keep this product away from pets and children. Used patches still contains the drug product that can produce serious adverse effect if child or pet chews or ingest this patch.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Condition worsens
• Symptoms persist for more than seven days or clear up and occur again within a few days
• Localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering where the product was applied.

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 and pets. If chewed or 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 over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Do not expose area to heat.

Children under 12 years of age: Consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.

Other information

SPL UNCLASSIFIED SECTION

.Store in a clean, dry place away from direct sunlight. Store in original unopened pouch. protected from moisture.

Questions ?

OTC - QUESTIONS SECTION

Customer Care Helpline 844-348-5423 Monday- Friday 8:30 a.m – 4:30 p.m PST

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label NDC 73638-901-01

image descriptionimage description

Pouch Label

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73638-901NIRAVI 24 HOURS LIDOCAINE 4 % PATCH (LIDOCAINE) PATCH [SPARSHA PHARMA USA, INC.]5Legacy NDC20241004_8b1c336b-bfcd-423b-bab3-464d119f5635.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73638-90173638-901-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
5aec9551-e180-4cf3-809a-b5a0206561618b1c336b-bfcd-423b-bab3-464d119f56352025-10-03WarningsExact identifier
spl set id: 8b1c336b-bfcd-423b-bab3-464d119f5635

Reported adverse events (FAERS/openFDA)#

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