2f98ee5e-e4eb-fbda-e063-6394a90a709c

SPL v4
SPL
SPL Set ID 2f98ee5e-e4eb-fbda-e063-6394a90a709c
Route
topical
Published
Effective Date 2025-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
levomenthol (1 g)
Inactive Ingredients
sodium polyacrylate (2500000 mw) water dihydroxyaluminum aminoacetate anhydrous kaolin propylene glycol edetate disodium carbomer tartaric acid polysorbate 80 povidone k90 glycerin carboxymethylcellulose sodium dmdm hydantoin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-01

Purpose

Purpose: Topical anesthetic

Description

4% lidocaine plus 1% menthol Pain Relief Patch, Package NDC Code: 85323-003-00


Medication Information

Warnings

Warnings (For external use only)

  • 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

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
  • 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.

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

Uses

Uses For temporary relief of pain

Purpose

Purpose: Topical anesthetic

Dosage and Administration

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 1 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

Directions

Uses For temporary relief of pain

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 1 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 apolication

Children under 12 years of age: consult a doctor

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients

Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.

Description

4% lidocaine plus 1% menthol Pain Relief Patch, Package NDC Code: 85323-003-00

Active Ingredient

Active Ingredients: ​4% lidocaine, 1% menthol

4% Lidocaine Plus 1% Menthol Pain Relief Patch, Package Ndc Code: 85323 003 00

4% lidocaine plus 1% menthol Pain Relief Patch, Package NDC Code: 85323-003-00


Structured Label Content

Warnings

Warnings (For external use only)

  • 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

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
  • 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.

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

Uses

Uses For temporary relief of pain

Purpose

Purpose: Topical anesthetic

Dosage and Administration (34068-7)

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 1 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

Directions

Uses For temporary relief of pain

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 1 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 apolication

Children under 12 years of age: consult a doctor

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients

Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.

Active Ingredient

Active Ingredients: ​4% lidocaine, 1% menthol

4% Lidocaine Plus 1% Menthol Pain Relief Patch, Package Ndc Code: 85323 003 00 (4% lidocaine plus 1% menthol Pain Relief Patch, Package NDC Code: 85323-003-00)

4% lidocaine plus 1% menthol Pain Relief Patch, Package NDC Code: 85323-003-00


Advanced Ingredient Data


Raw Label Data

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