Lidoguard Tm

Lidoguard Tm
SPL v2
SPL
SPL Set ID d8b021b6-cf71-4f7e-9d27-92d0982bd34f
Route
TOPICAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Alpha-tocopherol Acetate Aluminum Hydroxide Carbomer 940 Dmdm Hydantoin Glycerin Kaolin Polyacrylic Acid (250000 Mw) Polyvinyl Alcohol (100000 Mw) Water Sodium Polyacrylate (8000 Mw) Sorbitol Sorbitan Monooleate Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Lidocaine 4%

Purpose

External Anesthetic


Medication Information

Purpose

External Anesthetic

Description

Lidocaine 4%

Uses:

Temporarily relieves minor pain

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 50566-9

Stop use and ask doctor if

  • Your condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or a 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
Section 50567-7

When using the product

  • Use only as directed
  • Read and follow all directions and warnings on this label
  • Rare cases of serious burns have been reported with products of this type
  • Do not apply to wounds 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 a manner that always keeps the 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 burning sensation may occur upon application but generally disappears in several days
  • If a severe burning sensation occurs, discontinue use immediately
  • Discontinue use at least 1 hour before a bath or shower
  • Do not use immediately use after a bath or shower
Section 50570-1

Do not use

  • More than 1 patch on your body at a time
  • On cut, irritated or swollen skin on puncture wounds
  • For more than one week without consulting a doctor
  • At the same time as other topical analgesics
Section 51727-6

Inactive Ingredients:  Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminum Hydroxide, Aluminum Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Propylene Glycol, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartric Acid & Titanium Dioxide

Warnings:

For external use only

Directions

Adult 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 the middle
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • Use 1 patch for up to 12 hours



Children 12 years or younger:Ask a doctor

Drug Facts

Question Section

​Questions?  Call  877-227-3137

Active Ingredients

Lidocaine 4%

Other Information:

Store at room temperature 20° - 25°C (68°-77°F)

Principal Display Panel

NDC 85231-100-15

LidoGuard Pain Relief Patch

Pain Relieving Gel Patch

12hr Fast Acting Relief

Maximum Strength

15 Patches - Pain Relieving Gel Patch 

15 Patches 

3.94 in x 5.5 in EACH

Packaged For:

ViolaCare Inc.

Parsippany, New Jersey, 07054

Pregnancy Or Breast Feeding Section

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


Structured Label Content

Uses:

Temporarily relieves minor pain

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 50566-9 (50566-9)

Stop use and ask doctor if

  • Your condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or a 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
Section 50567-7 (50567-7)

When using the product

  • Use only as directed
  • Read and follow all directions and warnings on this label
  • Rare cases of serious burns have been reported with products of this type
  • Do not apply to wounds 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 a manner that always keeps the 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 burning sensation may occur upon application but generally disappears in several days
  • If a severe burning sensation occurs, discontinue use immediately
  • Discontinue use at least 1 hour before a bath or shower
  • Do not use immediately use after a bath or shower
Section 50570-1 (50570-1)

Do not use

  • More than 1 patch on your body at a time
  • On cut, irritated or swollen skin on puncture wounds
  • For more than one week without consulting a doctor
  • At the same time as other topical analgesics
Section 51727-6 (51727-6)

Inactive Ingredients:  Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminum Hydroxide, Aluminum Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Propylene Glycol, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartric Acid & Titanium Dioxide

Purpose

External Anesthetic

Warnings:

For external use only

Directions

Adult 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 the middle
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • Use 1 patch for up to 12 hours



Children 12 years or younger:Ask a doctor

Drug Facts

Question Section

​Questions?  Call  877-227-3137

Active Ingredients

Lidocaine 4%

Other Information: (Other information:)

Store at room temperature 20° - 25°C (68°-77°F)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 85231-100-15

LidoGuard Pain Relief Patch

Pain Relieving Gel Patch

12hr Fast Acting Relief

Maximum Strength

15 Patches - Pain Relieving Gel Patch 

15 Patches 

3.94 in x 5.5 in EACH

Packaged For:

ViolaCare Inc.

Parsippany, New Jersey, 07054

Pregnancy Or Breast Feeding Section (Pregnancy or breast feeding section)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)