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

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

aluminium hydroxide gel, bentonite, borax, carbomer, carboxymethylcellulose sodium,
colloidal silicon dioxide, dihydroxyaluminumaminoacetate, disodiumedetate, gelatin, glycerin, oleic acid, polysorbate 80, polyvinyl Alcohol, potassium Sorbate, povidone, propylene glycol, sodiummetabisulphite, tartaric acid, trolamine, urea, water

Package/Label Principal Display Panel

MAX STRENGTH LIDOCAINE PATCH

-NUMBS AWAY PAIN

lidocaine patch

MAXIMUM STRENGTH LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
ALGELDRATE (UNII: 03J11K103C)  
BENTONITE (UNII: A3N5ZCN45C)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLEIC ACID (UNII: 2UMI9U37CP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
TROLAMINE (UNII: 9O3K93S3TK)  
TARTARIC ACID (UNII: W4888I119H)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-067-115 in 1 CARTON03/06/2017
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 finalpart34803/06/2017
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)

Revised: 3/2017
Document Id: 4a16cbc7-24c4-6aa0-e054-00144ff8d46c
Set id: 6599240c-8610-4461-9a6c-a38b14dcdd69
Version: 2
Effective Time: 20170306
 
Velocity Pharma LLC