Lidopatch (10882-529-01, 10882-529-03, 10882-529-30)

Lidopatch (10882-529-01, 10882-529-03, 10882-529-30)
SPL v4
SPL
SPL Set ID 07289aa1-43ed-df31-e063-6394a90a764a
Route
TOPICAL
Published
Effective Date 2023-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (100 mg) Menthol (400 mg)
Inactive Ingredients
Propylparaben Carboxymethylcellulose Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Propylene Glycol Polyvinyl Alcohol, Unspecified Water Methylparaben Edetate Disodium Glycerin Tartaric Acid Dihydroxyaluminum Aminoacetate Polysorbate 80 Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-07

Description

Lidocaine 4% Menthol 1%

Purpose

Topical Analgesic Topical Analgesic


Medication Information

Indications and Usage

For temporary relief of pain.

Purpose

Topical Analgesic

Topical Analgesic

Description

Lidocaine 4% Menthol 1%

Section 50565-1

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

Section 51945-4

3ct box

outer box label

Section 60561-8

Questions? Email [email protected] or call 866-284-2948

Warnings

For external use only. Do not use if you are allergic or sensitive to lidocaine or menthol. Do not reuse, apply to intact skin only. Do not use if pouch is damaged or opened.

Handling and Disposal

  • hands should be washed after the handling and eye contact should be avoided
  • do not store patch outside the sealed pouch
  • apply immediately after removal from protective pouch
  • fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get them
  • kept out of the reach of children both before and after use

Stop use and ask a doctor if

  • excessive redness or irritation is present
  • condition worsens
  • pain persists 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.

Directions
  • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area
Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients

Dihydroxyaluminium Aminoacetate,Disodium EDTA,Glycerine ,Sopropyl Myristate, Methylparaben,Polysorbate 80,Polyvinyl Alcohol,Propylene Glycol,Propylparaben, Sodium Carboxymethyl Cellulose,Sodium Polyacrylate Tartaric Acid,Titanium Dioxide,

Water


Structured Label Content

Indications and Usage (34067-9)

For temporary relief of pain.

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 51945-4 (51945-4)

3ct box

outer box label

Section 60561-8 (60561-8)

Questions? Email [email protected] or call 866-284-2948

Purpose

Topical Analgesic

Topical Analgesic

Warnings

For external use only. Do not use if you are allergic or sensitive to lidocaine or menthol. Do not reuse, apply to intact skin only. Do not use if pouch is damaged or opened.

Handling and Disposal

  • hands should be washed after the handling and eye contact should be avoided
  • do not store patch outside the sealed pouch
  • apply immediately after removal from protective pouch
  • fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get them
  • kept out of the reach of children both before and after use

Stop use and ask a doctor if

  • excessive redness or irritation is present
  • condition worsens
  • pain persists 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.

Directions
  • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area
Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients

Dihydroxyaluminium Aminoacetate,Disodium EDTA,Glycerine ,Sopropyl Myristate, Methylparaben,Polysorbate 80,Polyvinyl Alcohol,Propylene Glycol,Propylparaben, Sodium Carboxymethyl Cellulose,Sodium Polyacrylate Tartaric Acid,Titanium Dioxide,

Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)