SPL v5
SPL
SPL Set ID fc23b2e2-4abc-4119-b8bd-305b4327f1dd
Route
TRANSDERMAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (567 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Kaolin Methylparaben Polyacrylic Acid (8000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Povidone K90 Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Drug Facts

Use

For the temporary relief of pain.

Section 42229-5

Drug Facts

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

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%

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 – 567 Mg Pouch Label

CVS

Health

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Numbing muscle & joint relief

For temporary relief of

minor aches & pains:

  • Arthritis
  • Bruises
  • Strains & sprains

Unscented

1 PATCH

3 15/16" x 5 1/2"

(10 cm x 14 cm)

Among over the counter

topical analgesics.

Principal Display Panel – 567 Mg Carton Label

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

Numbing muscle

& joint relief

For temporary relief of

minor aches & pains:

  • Arthritis
  • Bruises
  • Strains & sprains

Unscented

6 PATCHES

3 15/16" x 5 1/2" (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.


Structured Label Content

Use

For the temporary relief of pain.

Section 42229-5 (42229-5)

Drug Facts

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 Anesthetic

Warnings

For external use only

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%

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 – 567 Mg Pouch Label (Principal Display Panel – 567 mg Pouch Label)

CVS

Health

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain-Relieving

Patch

LIDOCAINE 4% GEL

Numbing muscle & joint relief

For temporary relief of

minor aches & pains:

  • Arthritis
  • Bruises
  • Strains & sprains

Unscented

1 PATCH

3 15/16" x 5 1/2"

(10 cm x 14 cm)

Among over the counter

topical analgesics.

Principal Display Panel – 567 Mg Carton Label (Principal Display Panel – 567 mg Carton Label)

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

Numbing muscle

& joint relief

For temporary relief of

minor aches & pains:

  • Arthritis
  • Bruises
  • Strains & sprains

Unscented

6 PATCHES

3 15/16" x 5 1/2" (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.


Advanced Ingredient Data


Raw Label Data

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