Zylotrol Maximum Pain Patch

Zylotrol Maximum Pain Patch
SPL v2
SPL
SPL Set ID a80efad7-1d8b-4d8b-8c97-373174ce89ca
Route
TOPICAL
Published
Effective Date 2022-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.03 g) Lidocaine (0.12 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: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-23
Description

Lidocaine 4% w/w Menthol 1% w/w

Purpose

Topical analgesic Topical analgesic

Medication Information

Purpose

Topical analgesic Topical analgesic

Description

Lidocaine 4% w/w Menthol 1% w/w

Uses

For the temporary relief of pain.

Purposes

Topical analgesic

Topical analgesic

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

Questions?

(310) 320-0100

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

Lidocaine 4% w/w

Menthol 1% w/w

Inactive Ingredients

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

When Using This Product:
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
 principal Display Panel

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

Structured Label Content

Uses

For the temporary relief of pain.

Purposes

Topical analgesic

Topical analgesic

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

Questions?

(310) 320-0100

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

Lidocaine 4% w/w

Menthol 1% w/w

Inactive Ingredients

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

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
 principal Display Panel ( Principal Display Panel)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:28.402060 · Updated: 2026-03-14T23:01:27.375563