LIDOCAINE- lidocaine patch 
7T Pharma LLC

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Lidocaine 3_5 Percent Patch


Drug Facts

Active ingredient

Lidocaine 3.5%

Purpose

Topical Anesthetic

Uses

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

Warnings

For external use only

Do not use

• 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

• 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:

• 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.

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

Directions

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

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

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

Inactive ingredients

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

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 89144

LIDOCAINE 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70645-735
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3.5 g
Inactive Ingredients
Ingredient NameStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TARTARIC ACID (UNII: W4888I119H)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70645-735-102 in 1 CARTON08/23/202103/01/2024
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/23/202103/01/2024
Labeler - 7T Pharma LLC (080220022)

Revised: 3/2024
 
7T Pharma LLC