THERACARE PAIN RELIEVING PATCH WITH LIDOCAINE- 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 Pain Relieving Patch with Lidocaine

Active Ingredients

Lidocaine 4%

Purpose

Topical anesthetic

Use

Temporary relieves minor pain

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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:

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, 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

TheraCare Pain Relieving Patch with Lidocaine

label

THERACARE PAIN RELIEVING PATCH WITH LIDOCAINE 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-918
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TARTARIC ACID (UNII: W4888I119H)  
KAOLIN (UNII: 24H4NWX5CO)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
WATER (UNII: 059QF0KO0R)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-918-121 g in 1 POUCH; Type 0: Not a Combination Product04/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2023
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.529128763manufacture(71101-918)

Revised: 4/2023
Document Id: f93b00e1-06d7-9066-e053-6294a90ae89a
Set id: f93b00e1-06d6-9066-e053-6294a90ae89a
Version: 1
Effective Time: 20230413
 
Veridian Healthcare