51452-172;zeey, Lidocaine&menthol Pain Relief Gel-patch, N 5, N 10, N 15

51452-172;zeey, Lidocaine&menthol Pain Relief Gel-patch, N 5, N 10, N 15
SPL v3
SPL
SPL Set ID 3a6e94c4-1ca6-e77a-e063-6394a90a4bfc
Route
TOPICAL
Published
Effective Date 2025-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.01 g) Lidocaine (0.04 g)
Inactive Ingredients
Kaolin Tartaric Acid Water Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Mineral Oil Polysorbate 80 Glycerin Edetate Disodium Povidone K90 Hydroxyacetophenone

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-21

Description

Lidocaine 4% w/w ...... Purpose: Topical anesthetic Menthol 1% w/w ...... Purpose: Topical analgesic

Purpose

Topical anesthetic (Lidocaine) Topical analgesic (Menthol)


Medication Information

Purpose

Topical anesthetic (Lidocaine) Topical analgesic (Menthol)

Description

Lidocaine 4% w/w ...... Purpose: Topical anesthetic Menthol 1% w/w ...... Purpose: Topical analgesic

Uses

Temporarily relieves minor pain.

Purposes

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours.

Children under 12 years of age: consult a physician.

Do Not Use:
  • More than 1 patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • lf you are allergic to any active or inactive ingredients
  • lf pouch is damaged or opened.
Active Ingredient

Lidocaine 4% w/w ...... Purpose: Topical anesthetic

Menthol 1% w/w ...... Purpose: Topical analgesic

Other Information
  • Store in a clean, dry place outside of direct sunlight, Protect from excessive moisture.
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,

Questions Or Comments

1-800-431-2830

When Using This Product:
  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not alow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches stil containthe drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use and Ask A Doctor If:

Condition worsens

Redness is present

lrritation develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

You experiencesigns of skin injury such as pain, swelling or blistering where the product was applied.

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

Package Label. Principal Display Panel


Structured Label Content

Uses

Temporarily relieves minor pain.

Purposes

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours.

Children under 12 years of age: consult a physician.

Do Not Use: (Do not use:)
  • More than 1 patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • lf you are allergic to any active or inactive ingredients
  • lf pouch is damaged or opened.
Active Ingredient

Lidocaine 4% w/w ...... Purpose: Topical anesthetic

Menthol 1% w/w ...... Purpose: Topical analgesic

Other Information (Other information)
  • Store in a clean, dry place outside of direct sunlight, Protect from excessive moisture.
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,

Questions Or Comments (Questions or Comments)

1-800-431-2830

When Using This Product: (When using this product:)
  • Use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not alow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches stil containthe drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Condition worsens

Redness is present

lrritation develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

You experiencesigns of skin injury such as pain, swelling or blistering where the product was applied.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

Ask a health professional before use

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

Package Label. Principal Display Panel (Package label. Principal display panel)


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