THERACARE LIDOCAINE PAIN RELIEF- lidocaine patch

Theracare Lidocaine Pain relief by

Drug Labeling and Warnings

Theracare Lidocaine Pain relief by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings

For external use only

Do not use

• more than one patch on your body at a time
• on cut or swollen skin
• on puncture wounds
• For more than one week without consulting a doctor if you are allergic to any active or inactive ingredients
• if pouch is damaged or opened

When using this product

• use only as directed
• read and follow all directions and warnings on this carton
• Do not allow contact with the eyes
• Do not use at the same time as other topical analgesics
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• Do not microwave
• Dispose of a used patch in a manner that always keeps the 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 ingest this patch.

Stop use and ask a doctor if

• conditions worsen
• Redness is present
• Irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of an injury, such as pain, swelling, or blistering where the product was applied.

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 800-222-1222 right away.

Directions

Adults and children 12 years of age and over:

• clean and dry affected area
• carefully remove the backing from the patch starting at a corner
• Apply the sticky side of patch to the affected area.
• Use one patch for up to 12 hours
• Discard patch after single use

Children under 12 years of age: consult a physician.

Other information

• store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive ingredients

aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions or comments?

Toll free 866-326-1313

Principal Display Panel

INGREDIENTS AND APPEARANCE

THERACARE LIDOCAINE PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-041
Route of Administration	PERCUTANEOUS, TOPICAL, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-041-06	6 in 1 BOX	07/01/2024
1		1 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/01/2024

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(71101-041)