Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 77978069-a1b4-473e-83c9-8320e00eea89
Route
TRANSDERMAL
Published
Effective Date 2024-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (240 mg) Menthol, Unspecified Form (60 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Kaolin Methylparaben Polyacrylic Acid (8000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Povidone, Unspecified Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-18

Description

Lidocaine 4% Menthol 1%.

Purpose

Topical Anesthetic Topical Analgesic


Medication Information

Purpose

Topical Anesthetic

Topical Analgesic

Description

Lidocaine 4% Menthol 1%.

Use

For the temporary relief of pain.

Section 50565-1

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

Section 53414-9

If pregnant or breast feeding ask a physician before use.

Warnings

For external use only

Directions
  • Adults/children 12 years and older
  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area
  • once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin
  • do not remove patch and reapply, this will result in the patch not sticking
  • avoid strenuous exercise while wearing patch, this will result in patch not sticking
  • do not use more than one patch in an 8 hour period.

Children 12 years or younger: ask a doctor.

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
Other Information

Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.

Active Ingredients

Lidocaine 4%

Menthol 1%.

Inactive Ingredients

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, Povidone, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this carton.
  • Do not use more than one patch in an 8 hour period. Maximum 3 patches per day.
  • 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 manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch
  • NOTE: patches may not adhere as well to all individuals, skin types, or certain parts of the body.
Stop Use and Ask A Doctor If
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms 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
Principal Display Panel – Box Label

CVS

Health®

Compare to the active ingredients

in IcyHot® Lidocaine Patch

Plus Menthol*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine Pain

Relief Patch

PLUS MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes

    aggravated nerves
  • Easy to apply
  • Fast acting

Topical Anesthetic

Topical Analgesic

Package Contains 5 Individually Wrapped Patches

5 PATCHES

3 15/16 IN X 5 1/2 IN (10 cm X 14 cm)

Pain-relieving ointment on a breathable adhesive pad

EACH PATCH IS SEALED IN A CHILD-RESISTANT POUCH FOR SAFETY

Among over-the-counter

topical analgesics.

Principal Display Panel – Patch Label

CVS

Health®

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine Pain

Relief Patch

PLUS MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes

    aggravated nerves
  • Easy to apply
  • Fast acting

Topical Anesthetic

Topical Analgesic

1 PATCH

3 15/16 IN X 5 1/2 IN

(10 cm X 14 cm)

Among over-the-counter

topical analgesics.


Structured Label Content

Use

For the temporary relief of pain.

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast feeding ask a physician before use.

Purpose

Topical Anesthetic

Topical Analgesic

Warnings

For external use only

Directions
  • Adults/children 12 years and older
  • clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area
  • once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin
  • do not remove patch and reapply, this will result in the patch not sticking
  • avoid strenuous exercise while wearing patch, this will result in patch not sticking
  • do not use more than one patch in an 8 hour period.

Children 12 years or younger: ask a doctor.

Do Not Use (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
Other Information (Other information)

Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.

Active Ingredients (Active ingredients)

Lidocaine 4%

Menthol 1%.

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, Povidone, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

When Using This Product (When using this product)
  • use only as directed. Read and follow all directions and warnings on this carton.
  • Do not use more than one patch in an 8 hour period. Maximum 3 patches per day.
  • 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 manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch
  • NOTE: patches may not adhere as well to all individuals, skin types, or certain parts of the body.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms 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
Principal Display Panel – Box Label

CVS

Health®

Compare to the active ingredients

in IcyHot® Lidocaine Patch

Plus Menthol*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine Pain

Relief Patch

PLUS MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes

    aggravated nerves
  • Easy to apply
  • Fast acting

Topical Anesthetic

Topical Analgesic

Package Contains 5 Individually Wrapped Patches

5 PATCHES

3 15/16 IN X 5 1/2 IN (10 cm X 14 cm)

Pain-relieving ointment on a breathable adhesive pad

EACH PATCH IS SEALED IN A CHILD-RESISTANT POUCH FOR SAFETY

Among over-the-counter

topical analgesics.

Principal Display Panel – Patch Label

CVS

Health®

MAXIMUM STRENGTH

Lidocaine concentration without a prescription†

Lidocaine Pain

Relief Patch

PLUS MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes

    aggravated nerves
  • Easy to apply
  • Fast acting

Topical Anesthetic

Topical Analgesic

1 PATCH

3 15/16 IN X 5 1/2 IN

(10 cm X 14 cm)

Among over-the-counter

topical analgesics.


Advanced Ingredient Data


Raw Label Data

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