MAXIMUM STRENGTH LIDOCAINE PATCH- lidocaine patch 
Velocity Pharma LLC

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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Maximum Strength Lidocaine Patch- Odorless-RA

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

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 dioxide.

Package label- Odorless Patch

Odorless-Patch_Carton-(Old-design)

MAXIMUM STRENGTH LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TARTARIC ACID (UNII: W4888I119H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-325-055 in 1 CARTON09/24/2019
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/24/2019
Labeler - Velocity Pharma LLC (962198409)

Revised: 10/2019
Document Id: 93eef152-43a5-5593-e053-2a95a90adaba
Set id: 6374c68a-fbf9-4d05-b25e-acd02ce7724a
Version: 3
Effective Time: 20191002
 
Velocity Pharma LLC