73557-175

73557-175
SPL v2
SPL
SPL Set ID 3ed51136-ea8e-8101-e063-6394a90acd4c
Route
TOPICAL
Published
Effective Date 2025-09-15
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 2025-09-15
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

For temporary relief of 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
  • 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

Do Not Use:
  • More than 1 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
Active Ingredient

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

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

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

Dihydroxyaluminium Aminoacetate, Edetate Disodium,Glycerin, Hydroxyacetophenone,Kaolin, Mineral Oil,Polysorbate 80, Polyacrylic Acid, Povidone K90, Propylene Glycol,Sodium Polyacrylate,Tartaric Acid,Titanium Dioxide,Water

Questions Or Comments

[email protected]

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

Package Label. Principal Display Panel

Structured Label Content

Uses

For temporary relief of 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
  • 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

Do Not Use: (Do not use:)
  • More than 1 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
Active Ingredient

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

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

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

Dihydroxyaluminium Aminoacetate, Edetate Disodium,Glycerin, Hydroxyacetophenone,Kaolin, Mineral Oil,Polysorbate 80, Polyacrylic Acid, Povidone K90, Propylene Glycol,Sodium Polyacrylate,Tartaric Acid,Titanium Dioxide,Water

Questions Or Comments (Questions or Comments)

[email protected]

When Using 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: (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, (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:03.844834 · Updated: 2026-03-14T23:10:14.816739