THERACARE PAIN RELIEF PATCH- lidocaine 4% patch

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Lidocaine 4.0%

Purpose

External analgesic

Use

For temporary relief of pain

Warnings

For External Use Only

Do not Use

over raw surfaces or blistered areas

When using this product

■ avoid contact with the eyes ■ do not use more than one patch on your body
at a time

Stop use and consult a doctor if

■ skin irritation develops ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding

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 (1-800-222-1222) right away

Directions

■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use.

■ Children under 2 years of age: Do not use, ask a doctor

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. Dispose of used patch in 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.

Inactive Ingredients

aluminum glycinate, benzyl alcohol, butylated hydroxy anisole, carboxymethylcellulose sodium, edetate disodium, ethylhexylglycerin, glycerin, kaolin, methacrylate copolymer, oleic acid, phenoxyethanol, polyacrylic acid, polysorbate 80, polyvinyl alcohol, povidone,
propylene glycol, sodium polyacrylate, sorbitol, tartaric acid, titanium dioxide, water

TheraCare Pain Relief Patch with 4% Lidocaine, 6-Count Paraben Free

INGREDIENTS AND APPEARANCE

THERACARE PAIN RELIEF PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-108
Route of Administration	TOPICAL

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
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)
OLEIC ACID (UNII: 2UMI9U37CP)
POLYVINYL ALCOHOL (UNII: 532B59J990)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-108-06	6 in 1 CARTON	04/01/2026
1		1 g in 1 PATCH; 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	04/01/2026

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Novamed Laboratories Private Limited		766401623	manufacture(71101-108)