Pain Relieving Patch

Pain Relieving Patch
SPL v10
SPL
SPL Set ID 02ed0b27-bba9-ec0c-e063-6294a90a014d
Route
TOPICAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.4 g)
Inactive Ingredients
Kaolin Propylparaben Sodium Polyacrylate (2500000 Mw) Povidone K90 Edetate Disodium Methylparaben Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Tartaric Acid Water Glycerin Polysorbate 80

Identifiers & Packaging

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

Description

LIDOCAINE PATCH 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

LIDOCAINE PATCH 4%

Use

For the temporary relief of pain

Warnings

For external use only

Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds

for more than one week without consulting a doctor

Directions

Adults and children 12 years of age and older:

Wash and dry the affected area.

Peel off the backing film from one side of the patch carefully

Apply the exposed portion of the patch to the affected area.

Gently press the patch with your hand to fit the affected area completely.

Do not exercise vigorously during use to prevent the patch from falling off.

Use only 1 patch for a maximum of 8 hours.

Children under 12 years of age: Ask a doctor before use.

Drug Facts

LIDOCAINE PATCH 4%

Do Not Use:
  • More than 1 patch at a time
  • On wounds or damaged skin
  • For more than one week without consulting a doctor
  • If you are allergic to any ingredients of this product
Active Ingredient

Lidocaine 4%

Other Information
  • Store at room temperature 15°-30°C (59°-86°F)
  • Store in a cool dry place away from direct sunlight
Inactive Ingredient

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Povidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Questions Or Comments:
When Using This Product

Use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes

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 analcesics

dispose of used patch in manner that always keeps 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.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Stop Use and Ask A Doctor If:
  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Condition worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding:

Ask a health professional before use

Package Label. Principal Display Panel:


Structured Label Content

Use (USE)

For the temporary relief of pain

Purpose

Topical anesthetic

Warnings

For external use only

Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds

for more than one week without consulting a doctor

Directions

Adults and children 12 years of age and older:

Wash and dry the affected area.

Peel off the backing film from one side of the patch carefully

Apply the exposed portion of the patch to the affected area.

Gently press the patch with your hand to fit the affected area completely.

Do not exercise vigorously during use to prevent the patch from falling off.

Use only 1 patch for a maximum of 8 hours.

Children under 12 years of age: Ask a doctor before use.

Drug Facts

LIDOCAINE PATCH 4%

Do Not Use: (DO NOT USE:)
  • More than 1 patch at a time
  • On wounds or damaged skin
  • For more than one week without consulting a doctor
  • If you are allergic to any ingredients of this product
Active Ingredient

Lidocaine 4%

Other Information (Other information)
  • Store at room temperature 15°-30°C (59°-86°F)
  • Store in a cool dry place away from direct sunlight
Inactive Ingredient (Inactive ingredient)

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Povidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Questions Or Comments: (QUESTIONS OR COMMENTS:)
When Using This Product (When using this product)

Use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes

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 analcesics

dispose of used patch in manner that always keeps 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.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Stop Use and Ask A Doctor If: (STOP USE AND ASK A DOCTOR IF:)
  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Condition worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding: (IF PREGNANT OR BREAST-FEEDING:)

Ask a health professional before use

Package Label. Principal Display Panel: (PACKAGE LABEL. PRINCIPAL DISPLAY PANEL:)


Advanced Ingredient Data


Raw Label Data

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