LIDOPATCH- lidocaine, menthol patch 
J.A.R. Laboratories

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Lidopatch

WARNINGS SECTION
For external use only. Do not use if you are allergic or sensitive to lidocaine or menhol. Do not use if pouch is damaged or opened.

PURPOSE

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle straints, sprains and bruises.


ACTIVE INGREDIENT SECTION
Lidocaine HCL 3.6% - Topical analgesic
Menthol 1.25% - Topical analgesic

STOP USE SECTION
Stop Use and ask doctor if:
excessive redness or irritation is present
Pain persists for more than 7 days
symptoms cear up and occur again within a few days
conditions worsens
If pregnant or breasfeading, ask a health professional before use. keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION


Directions: Aduts apply patch to affected area for a maximum of 12 hours.
Do not use more than 1 patch every 24 hours.
children : consult your physician
remove protective film, gently apply to affected area.

INACTIVE INGREDIENT SECTION


Dihydroxyaluminum aminoacetate, Disodium EDTA, Glycerine, Methylparaben, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Propyl paraben, Sodium, Carboxymethylcellulose, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water

Usage
Aduts apply patch to affected area for a maximum of 12 hours.
Do not use more than 1 patch every 24 hours

KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL

LABEL

LIDOPATCH 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10882-527
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.036 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.0125 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10882-527-011 in 1 PACKAGE; Type 0: Not a Combination Product03/02/2016
2NDC:10882-527-0230 in 1 PACKAGE; Type 0: Not a Combination Product03/02/2016
3NDC:10882-527-0430 in 1 PACKAGE; Type 0: Not a Combination Product03/02/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/02/201610/03/2023
Labeler - J.A.R. Laboratories (968952239)
Establishment
NameAddressID/FEIBusiness Operations
Bingbing Pharmaceutical (Hubei) Co., Ltd554413454manufacture(10882-527)
Establishment
NameAddressID/FEIBusiness Operations
INTERMED676244169manufacture(10882-527)

Revised: 10/2023
 
J.A.R. Laboratories