PAIN RELIEVING LIDOCAINE PATCH- lidocaine patch 
InterMed Laboratories Private Limited

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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YYBA - Welmate Lidocaine Pain Relieving Patch (73581-001)

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily 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 right away.

Directions

Adults and children over 12 years:

children 12 years or younger:ask a doctor

Inactive Ingredients

dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric acid, titanium oxide

Package/Label Principal Display Panel

1V

40

PAIN RELIEVING LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71811-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71811-003-3030 in 1 CARTON09/17/2020
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:71811-003-4040 in 1 CARTON09/17/2020
21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/17/2020
Labeler - InterMed Laboratories Private Limited (676244169)

Revised: 7/2023
Document Id: 01d3b2bb-3945-083e-e063-6394a90a7816
Set id: 01d3b2bb-3944-083e-e063-6394a90a7816
Version: 1
Effective Time: 20230728
 
InterMed Laboratories Private Limited