Zylotrol Maximum Pain Patch

Manufacturer
Whitestone Products LLC
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:46

Label at a glance#

ProductZylotrol Maximum Pain Patch
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure14 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

OTC - PURPOSE SECTION

Topical Analgesic

WARNINGS SECTION

For external use onlynot intended for ingestion.

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces, or blistered areas.

OTC - WHEN USING SECTION

  • Avoid contact with eyes.

OTC - ASK DOCTOR SECTION

  • condition worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily.
  • Children under 2 years of age: consult a doctor.

OTHER SAFETY INFORMATION

  • Store at 20-25oC (68-77oF) and protect from moisture.

INACTIVE INGREDIENT SECTION

polyacrylamide, vinol, sodium polyacrylate; acrylate polymerization; purified water.

Questions?

OTC - QUESTIONS SECTION

(310) 320-0100

USES

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-101-15EA - Each81902-10150ecf376-67cd-4d9b-bc6b-08a3511d5e3012021-09-07

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81902-10181902-101-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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
323e3da2-d78e-9ef8-e063-6394a90ad548c85c3ee8-1679-efdb-e053-2a95a90a57102025-04-08WarningsExact identifier
spl set id: c85c3ee8-1679-efdb-e053-2a95a90a5710

Reported adverse events (FAERS/openFDA)#

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