MAXIMUM STRENGTH LIDOCAINE PATCH- lidocaine patch 
Intermed

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- Bulk Listing

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.

Bulk Package Label

500600

MAXIMUM STRENGTH LIDOCAINE PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71811-001
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71811-001-05500 in 1 BOX09/24/2019
15 in 1 CARTON; Type 0: Not a Combination Product
2NDC:71811-001-06600 in 1 BOX09/24/2019
25 in 1 CARTON; 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 - Intermed (676244169)
Registrant - Velocity Pharma LLC (962198409)
Establishment
NameAddressID/FEIBusiness Operations
Intermed676244169manufacture(71811-001)

Revised: 10/2021
Document Id: cf30210f-e118-9d71-e053-2995a90a4d6f
Set id: 83befa6f-d127-4124-9d1f-44a723eec908
Version: 7
Effective Time: 20211025
 
Intermed