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- RA

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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

pain-relieving-patch-6ct_Carton-(Old-design)

MAXIMUM STRENGTH LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-305
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TARTARIC ACID (UNII: W4888I119H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-305-066 in 1 CARTON09/23/2019
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 finalpart34809/23/2019
Labeler - Velocity Pharma LLC (962198409)

Revised: 10/2019
Document Id: 93ef4b87-3e4a-328e-e053-2995a90a70dd
Set id: cd761b07-d82f-4299-875e-51b757f9c2df
Version: 3
Effective Time: 20191002
 
Velocity Pharma LLC