globe pain relief gel-patch

globe pain relief gel-patch
SPL v3
SPL
SPL Set ID 12a27ce7-c547-7134-e063-6394a90a94bd
Route
topical
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
polyacrylic acid (8000 mw) polysorbate 80 tartaric acid methylparaben sodium polyacrylate (8000 mw) titanium dioxide water glycerin propylene glycol kaolin edetate sodium povidone k90 propylparaben dihydroxyaluminum aminoacetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-28
Purpose

Topical Anesthetic

Description

Lidocaine 4%

Medication Information

Warnings

For External Use Only

Indications and Usage

For temporary relief of pain

Purpose

Topical Anesthetic

Directions

Adult and children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from teh skin after at most 8-hour application
  • Children under 12 years of age. Consult a doctor
Other Information
  • Store at controlled room temperature 68º-77ºF (20º-25ºC)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Description

Lidocaine 4%

Section 51945-4

Do Not Use
  • More than 1 patch at a time
  • On wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4802

Active Ingredient

Lidocaine 4%

Questions Or Comments

Call 1-888-296-9067

When Using This Product
  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly
Stop Use and Ask A Doctor
  • Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Condition worsens
  • 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

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For External Use Only

Indications and Usage (34067-9)

For temporary relief of pain

Purpose

Topical Anesthetic

Directions

Adult and children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from teh skin after at most 8-hour application
  • Children under 12 years of age. Consult a doctor
Other Information (Other information)
  • Store at controlled room temperature 68º-77ºF (20º-25ºC)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Section 51945-4 (51945-4)

Do Not Use
  • More than 1 patch at a time
  • On wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4802

Active Ingredient

Lidocaine 4%

Questions Or Comments (Questions or Comments)

Call 1-888-296-9067

When Using This Product (When Using this product)
  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Condition worsens
  • 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

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

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.825585 · Updated: 2026-03-14T23:10:51.714911