Lidocaine and Menthol Patch

Lidocaine and Menthol by

Drug Labeling and Warnings

Lidocaine and Menthol by is a Otc medication manufactured, distributed, or labeled by 7T Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOCAINE AND MENTHOL- lidocaine and menthol patch 
7T Pharma LLC

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Lidocaine and Menthol Patch

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

Active ingredient

Purpose

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

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

Uses

Temporarily relieves minor aches and muscle pains associated with:

arthritis

simple backache

strains

muscle soreness

muscle stiffness

Warnings

For external use only.

Read all warnings and directions before use.

Do not use

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

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:

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.

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

Directions

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

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

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

Inactive ingredients

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

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: <a href=/NDC/70645-701-15>70645-701-15</a>
15 Articulated Patches (5 per Resealable Pouch X 3 )per Box
Manufactured for: 
7T Pharma, LLC
Las Vegas, NV 89144

LIDOCAINE AND MENTHOL 
lidocaine and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70645-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LEMON OIL (UNII: I9GRO824LL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70645-701-1515 in 1 BOX; Type 0: Not a Combination Product06/01/202103/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/01/202103/01/2024
Labeler - 7T Pharma LLC (080220022)

Revised: 3/2024
 

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