ZYLOTROL MAXIMUM PAIN PATCH

Manufacturer
Whitestone Products LLC
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-25 01:02:19

Label at a glance#

ProductZYLOTROL MAXIMUM PAIN
Active ingredientMENTHOL, LIDOCAINE
Label structure14 sections

Indications and uses

For the temporary relief of pain.

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purposes

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

  • More than 1 patch at a time
  • On wounds or damaged skin
  • If you are allergic to any ingredients of this product

When using this product:

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

(888) 726-7848

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-104-15EA - Each81902-104c498d81e-2515-4da8-9ee2-b17d3ba709c512023-04-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81902-10481902-104-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-10-21full-release2026-05-31 23:57:08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYLOTROL MAXIMUM PAINLIDOCAINE 4%, MENTHOL 1%Whitestone Products LLCa80efad7-1d8b-4d8b-8c97-373174ce89ca2026-08-21WarningsExact identifier
ndc (package): 81902-104-15
ndc (product): 81902-104
ndc11 (package): 81902010415
spl id: 5987c89d-0894-d082-e063-6394a90a269e
spl set id: a80efad7-1d8b-4d8b-8c97-373174ce89ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.