Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID d07fdffd-bf7c-4950-9b2d-c06d54ef4c55
Route
TRANSDERMAL
Published
Effective Date 2023-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 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 2020-06-02

Description

Lidocaine 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4%

Use

For the temporary relief of pain.

Section 42229-5

Children 12 years or younger:ask a doctor.

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 feedingask 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 a 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.
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
Active Ingredient

Lidocaine 4%

Other Information

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

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 – Carton Label

CVS

Health ®

Compare to the active

ingredients in Salonpas ®

4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain-Relieving

Patches

LIDOCAINE 4% GEL

Desensitizes

aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

6ASSORTED SIZE PATCHES

2 SM 3 1/8” x 4 ¾” (8 cm x 12 cm)

2 MED 3 15/16” x 5 1/2” (10 cm x 14 cm)

2 XL 5 1/2” x 9 7/8” (14 cm x 25 cm)

Pain-relieving ointment on a breathable adhesive pad

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

ASSORTED

SIZES

Principal Display Panel – Small Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS

Health ®

Compare to the active ingredient in

Salonpas ®4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

Among over the counter

topical analgesics.

1PATCH | SMALL

3 1/8” x 4 3/4” (8 cm x 12 cm)

Principal Display Panel – Medium Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS

Health®

Compare to the active ingredient in

Salonpas ®4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

Among over the counter

topical analgesics.

1PATCH | MEDIUM

3 15/16” x 5 1/2” (10 cm x 14 cm)

Principal Display Panel – X Large Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS

Health ®

Compare to the active ingredient in

Salonpas ®4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

Among over the counter

topical analgesics.

1PATCH | X LARGE

5 1/2” x 9 7/8” (14 cm x 25 cm)


Structured Label Content

Use

For the temporary relief of pain.

Section 42229-5 (42229-5)

Children 12 years or younger:ask a doctor.

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 feedingask a physician before use.

Purpose

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 a 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.
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
Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

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

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 – Carton Label

CVS

Health ®

Compare to the active

ingredients in Salonpas ®

4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain-Relieving

Patches

LIDOCAINE 4% GEL

Desensitizes

aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

6ASSORTED SIZE PATCHES

2 SM 3 1/8” x 4 ¾” (8 cm x 12 cm)

2 MED 3 15/16” x 5 1/2” (10 cm x 14 cm)

2 XL 5 1/2” x 9 7/8” (14 cm x 25 cm)

Pain-relieving ointment on a breathable adhesive pad

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

ASSORTED

SIZES

Principal Display Panel – Small Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS

Health ®

Compare to the active ingredient in

Salonpas ®4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

Among over the counter

topical analgesics.

1PATCH | SMALL

3 1/8” x 4 3/4” (8 cm x 12 cm)

Principal Display Panel – Medium Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS

Health®

Compare to the active ingredient in

Salonpas ®4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

Among over the counter

topical analgesics.

1PATCH | MEDIUM

3 15/16” x 5 1/2” (10 cm x 14 cm)

Principal Display Panel – X Large Patch Label

CUT OPEN POUCH AND REMOVE PATCH

CVS

Health ®

Compare to the active ingredient in

Salonpas ®4% Lidocaine Gel Patch*

MAXIMUM STRENGTH

Lidocaine concentration without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Desensitizes aggravated nerves

  • Fast acting
  • Easy to apply
  • No irritation or burning

Unscented

Among over the counter

topical analgesics.

1PATCH | X LARGE

5 1/2” x 9 7/8” (14 cm x 25 cm)


Advanced Ingredient Data


Raw Label Data

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