TheraCare Maximum Strength Pain Relief Patch

TheraCare Maximum Strength Pain Relief Patch by

Drug Labeling and Warnings

TheraCare Maximum Strength Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Unexo Life Sciences, Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH- lidocaine patch 
Veridian Healthcare

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TheraCare Maximum Strength Pain Relief Patch

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Use

temporary relieves minor pain

Warnings

For external use only

Do not use

• more than 1 patch on your body at a time
• on cut, irritated 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 used patch in manner that always keeps product away from children or 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 use and ask a doctor if

• condition worsens
• 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 skin 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 1-800-222-1222 right away.

Directions

adults and children 12 years of age and over:

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

Other information

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

Inactive ingredients

aluminum glycinate, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal display panel

THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-001-06	6 in 1 CARTON	05/01/2022
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71101-001-24	1 in 1 POUCH; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2022

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences, Private Limited		872260479	manufacture(71101-001)

Revised: 12/2022

Document Id: ef576143-b5b3-f9fa-e053-2995a90a19be

34390-5

Set id: dfaf8a77-2276-4791-e053-2a95a90a3288

Version: 2

Effective Time: 20221208