Alivio 4%

Alivio 4%
SPL v5
SPL
SPL Set ID eb3a98f1-c875-4f08-8b4b-44e22626b609
Route
TRANSDERMAL
Published
Effective Date 2022-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Alpha-tocopherol Acetate Aluminum Hydroxide Aluminum Silicate Butylated Hydroxytoluene Mineral Oil Rosin Silicon Dioxide Styrene/isoprene/styrene Block Copolymer Titanium Dioxide Isoprene Isobutylene Polyisobutylene (1000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-16

Description

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


Medication Information

Description

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

Use

Temporarily relieves minor pain

Section 42229-5

Distributed in US by:

Amerise Pharmaceuticals LLC

6 Corporate Dr, Cranbury, NJ 08512

Customer Care NO.: 609-721-9587

Email: [email protected]

Section 50565-1

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Section 55105-1

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.

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

Active Ingredients

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

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


Structured Label Content

Use

Temporarily relieves minor pain

Section 42229-5 (42229-5)

Distributed in US by:

Amerise Pharmaceuticals LLC

6 Corporate Dr, Cranbury, NJ 08512

Customer Care NO.: 609-721-9587

Email: [email protected]

Section 50565-1 (50565-1)

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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.

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

Active Ingredients

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

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


Advanced Ingredient Data


Raw Label Data

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