ALIVIO- lidocaine patch 
Amerise Pharmaceuticals 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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Alivio 4%

Lidocaine 4% Patch

Transdermal Pain Relief Patch

Active Ingredients

Lidocaine 4% .................................... Topical Anesthetic

Use

Temporarily relieves minor pain

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

alpha-tocopherol acetate, aluminum hydroxide, aluminum silicate, butylated hydroxytoluene, butyl rubber, isoprene rubber, mineral oil, polyisobutylene, rosin, silicon dioxide, styrene/isoprene/styrene block, titanium dioxide

Distributed in US by:

Amerise Pharmaceuticals LLC

6 Corporate Dr, Cranbury, NJ 08512

Customer Care NO.: 609-721-9587

Email: help@amerisepharma.com

Carton Image

Pouch Image

Lidocaine Carton - 3 pack

ALIVIO 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82598-101
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MINERAL OIL (UNII: T5L8T28FGP)  
ROSIN (UNII: 88S87KL877)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ISOPRENE (UNII: 0A62964IBU)  
ISOBUTYLENE (UNII: QA2LMR467H)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82598-101-2020 in 1 CARTON06/17/2022
1NDC:82598-101-011 in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:82598-101-033 in 1 CARTON; Type 0: Not a Combination Product06/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/16/2022
Labeler - Amerise Pharmaceuticals LLC (089951382)

Revised: 11/2022
Document Id: ee0fd188-1a8e-1b34-e053-2a95a90a0315
Set id: eb3a98f1-c875-4f08-8b4b-44e22626b609
Version: 2
Effective Time: 20221122
 
Amerise Pharmaceuticals LLC