Lidocaine and Menthol Patch

Manufacturer
7T Pharma LLC
Effective date
2021-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:44:11

Label at a glance#

ProductLidocaine and Menthol
Active ingredientLIDOCAINE, MENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor aches and muscle pains associated with: • arthritis • simple backache • strains • muscle soreness • muscle stiffness

Dosage and administration

Adults and children 12 years of age and older: Apply 1 patch to the affected area of intact skin 1 to 2 times daily or as directed. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area. - Open pouch and remove one patch. - Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap a...

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

Lidocaine 4% and Menthol 4% Patch

7T Pharma, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine 4% and Menthol 4% Patch


Drug Facts

Purpose

OTC - PURPOSE SECTION

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

Menthol 4%.....................................................................................................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and muscle pains associated with:

• arthritis

• simple backache

• strains

• muscle soreness

• muscle stiffness

Warnings

WARNINGS SECTION

For external use only.

Read all warnings and directions before use.

Do not use

OTC - DO NOT USE SECTION

• More than one patch at a time.

• On wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

• With a heating pad or cover with bandage.

• If you are allergic to any ingredients of this product

Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

When using this product

OTC - WHEN USING SECTION

• Use only as directed. 

• Avoid contact with eyes, mucous membranes, or rashes

• Do not tightly wrap or bandage the treated area

Stop use and ask a physician:

SPL UNCLASSIFIED SECTION

• If pregnant or breast feeding

• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

Apply 1 patch to the affected area of intact skin 1 to 2 times daily or as directed. Do not leave patch on for more than 8 hours at a time.

- Clean and dry the affected area.

- Open pouch and remove one patch.

- Remove any protective film and apply directly to affected area of pain. 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: Ask 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

Aqua (Deionized Water), Glycerine, Sodium Polyacrylate, Polysorbate 80, EDTA Disodium salt, Methylparaben, Citrus Medica Limonum (Lemon) Peel Oil, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Propylparaben

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 4% and Menthol 4% Topical Pain Patch

NDC 70645-701-15

15 Articulated Patches (5 per Resealable Pouch X 3 )per Box

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

PRINCIPAL DISPLAY PANEL Lidocaine 4% and Menthol 4% Topical Pain Patch NDC 70645-701-15 15 Articulated Patches (5 per Resealable Pouch X 3 )per Box Manufactured for: 7T Pharma, ...PRINCIPAL DISPLAY PANEL Lidocaine 4% and Menthol 4% Topical Pain Patch NDC 70645-701-15 15 Articulated Patches (5 per Resealable Pouch X 3 )per Box Manufactured for: 7T Pharma, ...

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70645-701-152024-03-06C16284748780-1f386c64a-26b9-0266-e053-dadaa90a7c1aLidocaine and Menthol Patch
70645-701-152023-01-30C16284748780-1f386c64a-26b9-0266-e053-dadaa90a7c1aLidocaine and Menthol Patch

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70645-701-15EA - Each70645-7016f514fcf-1394-41b1-8375-ecdff59497f612021-08-05

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
70645-70170645-701-15

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
b9a0f899-ed02-49cc-a73a-d4341df3f45f54078c12-98a3-4c9a-81a0-4415ecfd80112024-03-11WarningsExact identifier
spl set id: 54078c12-98a3-4c9a-81a0-4415ecfd8011

Reported adverse events (FAERS/openFDA)#

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