THERACARE 2X MEDICATED PAIN RELIEF- lidocaine, menthol patch

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

Menthol 1%

Purpose

External Analgesic

Uses

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

■ 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 12 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 12 years of age: Do not use, ask a doctor

Other Safety 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

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid,

titanium dioxide, water

Questions

Call toll free 1-866-326-1313

TheraCare 2X Medicated Pain Relief Patch 5 Ct.

INGREDIENTS AND APPEARANCE

THERACARE 2X MEDICATED PAIN RELIEF 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PETROLATUM (UNII: 4T6H12BN9U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-127-01	5 in 1 CARTON	04/01/2026
1		9 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
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(71101-127)