Lidocaine 3_5 Percent Patch

Manufacturer
7T Pharma LLC
Effective date
2022-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:06:36

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of joint pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. 

Dosage and administration

Adults and children 12 years of age and older: Apply 1 patch topically to affected area of intact skin for up to 12 hours a day Clean and dry the affected area. Open pouch and remove one patch. Remove backing from patch. Carefully apply patch directly to affected area. Apply immediately after removal from the protective envelope. Wash hands with soap and water after handling the patches. Reseal pouch containing un...

Storage and handling

Store at room temperature 15°-30°C (59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture. 

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 3.5%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of joint pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. 

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• More than 1 patch on your body at a time or on irritated or swollen skin

• On wounds, damaged or infected skin

• On eyes, mouth, genitals or other mucous membranes

When using this product

OTC - WHEN USING SECTION

• Use only as directed. Read and follow all directions and warnings on this carton and packet insert.

• Do not allow contact with the eyes.

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

• Do not use at the same time as other topical analgesics or anesthetics.

• Dispose of used patch in a 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 and consult a physician:

OTC - STOP USE SECTION

• If condition or pain worsens

• If you are allergic to any of the ingredients in this product

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

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

• If using concurrently with any other external pain-relieving products

If pregnant or breast-feeding, 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

Adults and children 12 years of age and older:

Apply 1 patch topically to affected area of intact skin for up to 12 hours a day

  • Clean and dry the affected area.
  • Open pouch and remove one patch. Remove backing from patch.
  • Carefully apply patch directly to affected area. Apply immediately after removal from the protective envelope.
  • Wash hands with soap and water after handling the patches.
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
  • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 12 years: Consult a physician

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Polyvinyl alcohol, non-crystallizing sorbitol solution, polyacrylic acid, glycerin, carboxymethylcellulose sodium, colloidal silicon dioxide, titanium dioxide, propylene glycol, tartaric acid, magnesium hydroxide, sodium polyacrylate, purified water.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 3.5% Patch

NDC 70645-735-10

10 Patches (5 per Resealable Pouch X 2)

Manufactured for:
7T Pharma, LLC
Las Vegas, NV 89144

Lidocaine 3.5% Patch NDC 70645-735-10 10 Patches (5 per Resealable Pouch X 2) Manufactured for: 7T Pharma, LLC Las Vegas, NV 89144Lidocaine 3.5% Patch NDC 70645-735-10 10 Patches (5 per Resealable Pouch X 2) Manufactured for: 7T Pharma, LLC Las Vegas, NV 89144

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70645-735-102024-03-06C16284748780-11030e365-5be4-111a-e063-dadaa90a10e2Lidocaine 3_5 Percent Patch
70645-735-102024-01-30C16284748780-11030e365-5be4-111a-e063-dadaa90a10e2Lidocaine 3_5 Percent Patch

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70645-735-10EA - Each70645-735a85c8e82-eaac-4055-8c41-fda69550a04a12022-04-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70645-73570645-735-10

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
c943ebcf-bcc9-4f85-9aee-96513e28bec0eca766bf-0d27-48ad-b9bb-1d84b642e5fb2024-03-11WarningsExact identifier
spl set id: eca766bf-0d27-48ad-b9bb-1d84b642e5fb

Reported adverse events (FAERS/openFDA)#

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