THERACARE PAIN RELIEF 4% LIDOCAINE- lidocaine patch

TheraCare Pain Relief 4% Lidocaine by

Drug Labeling and Warnings

TheraCare Pain Relief 4% Lidocaine by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, InterMed Laboratories Private Limited. 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

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyacrylic acid, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

Toll free 866-326-1313

Principal Display Panel

INGREDIENTS AND APPEARANCE

THERACARE PAIN RELIEF 4% LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-059
Route of Administration	TOPICAL, PERCUTANEOUS, 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)
POLYVINYL ALCOHOL (UNII: 532B59J990)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-059-05	5 in 1 BOX	02/01/2025
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	02/01/2025

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
InterMed Laboratories Private Limited		676244169	manufacture(71101-059)