Alivio by Amerise Pharmaceuticals LLC ALIVIO- lidocaine patch

Alivio by

Drug Labeling and Warnings

Alivio by is a Otc medication manufactured, distributed, or labeled by Amerise Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Use

Temporarily relieves minor pain

PURPOSE

Temporarily relieves minor pain

Warnings

For external use only.

Do not use

• more than 1 patch on your body at a time or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When using this product

• use only as directed. Read and follow all directions and warning on this carton
• rare cases of serious burns have been reported with products of this type
• do not apply to wonds or damaged, broken or irritated skin
• do not allow contact with the eyes and mucous membranes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• dispose of used patch in manner that always keep product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
• a transient buring sensation may occur upon applicaiton but generally disappears in several day
• if a severe buring sensation occurs, discontinue use immediately

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• sypmtoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
• use 1 patch for up to 12 hours

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

SPL UNCLASSIFIED SECTION

Distributed in US by:

Amerise Pharmaceuticals LLC

6 Corporate Dr, Cranbury, NJ 08512

Customer Care NO.: 609-721-9587

Email: help@amerisepharma.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALIVIO 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82598-101
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82598-101-20	20 in 1 CARTON	06/17/2022
1	NDC: 82598-101-01	1 in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 82598-101-03	3 in 1 CARTON; Type 0: Not a Combination Product	06/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/16/2022

Labeler - Amerise Pharmaceuticals LLC (089951382)