f993ed5f-7dbb-4e3e-addf-f65b12f5cc48

SPL v2
SPL
SPL Set ID f993ed5f-7dbb-4e3e-addf-f65b12f5cc48
Route
topical
Published
Effective Date 2024-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g) menthol (1 g)
Inactive Ingredients
dihydroxyaluminum aminoacetate edetate disodium glycerin hydroxyacetophenone kaolin tartaric acid mineral oil polysorbate 80 polyacrylic acid (250000 mw) povidone k90 propylene glycol sodium polyacrylate (2500000 mw) titanium dioxide water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-18

Purpose

Lidocaine 4%                           Topical anesthetic Menthol 1%                            Topical analgesic

Description

Lidocaine 4%                           Topical anesthetic Menthol 1%                            Topical analgesic


Medication Information

Warnings

For external use only

Do not use

  • More than one 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 

When using this product

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Stop use and ask a doctor if :

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions 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

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

Uses

For the temporary pain relief

Purpose

Lidocaine 4%                           Topical anesthetic Menthol 1%                            Topical analgesic

Directions

Adult and Children 12 years of age and over

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply one patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age : Consult a doctor

Other Information
  • Store at 68° - 77°F ( 20° - 25°C)
  • Store in a cool dry place away from direct sunlight
Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)- Tartaric Acid, Mineral oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water

Description

Lidocaine 4%                           Topical anesthetic Menthol 1%                            Topical analgesic

Product Label

Active Ingredient                            Purpose

Lidocaine 4%                           Topical anesthetic

Menthol 1%                            Topical analgesic


Structured Label Content

Warnings

For external use only

Do not use

  • More than one 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 

When using this product

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Stop use and ask a doctor if :

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions 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

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

Uses

For the temporary pain relief

Directions

Adult and Children 12 years of age and over

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply one patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age : Consult a doctor

Other Information (Other information)
  • Store at 68° - 77°F ( 20° - 25°C)
  • Store in a cool dry place away from direct sunlight
Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)- Tartaric Acid, Mineral oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water

Product Label (Product label)

Active Ingredient                            Purpose

Lidocaine 4%                           Topical anesthetic

Menthol 1%                            Topical analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)