Zylotrol-L

Manufacturer
Whitestone Products LLC
Effective date
2022-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:51:13

Label at a glance#

ProductZylotrol-L
Active ingredientLIDOCAINE, ISOPROPYL ALCOHOL
Label structure22 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 12 years of age or over: Clean and dry the affected area Open pouch and remove one patch Apply 1 patch at a time to affected area; not more than 3 to 4 times daily Reseal pouch containing unused patches after each use Remove patch from the skin after at most 8-hour application Children under 12 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use:

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

OTC - WHEN USING SECTION

When using this product:

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

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age:

  • Consult a doctor

Other Information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

SPL UNCLASSIFIED SECTION

Questions or comments? 866-747-7365

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use

INDICATIONS & USAGE SECTION

For preparation of the skin prior to an injection

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from fire or flame

OTC - DO NOT USE SECTION

  • Do not use with electrocautery procedures
  • Do not use in the eyes
  • Do not apply to irritated skin

OTC - STOP USE SECTION

  • Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out from reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Open packet
  • Remove pad
  • Apply topically as needed to cleanse intended area. Discard after single use.

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature 59-86°F (15-30°C)
  • Contents sterile in unopened, undamaged package

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC: 81902-303-15

Zylotrol TM-L

Pacakge Contains:

15 Lidocaine 4% Patches

15 Isopropyl Alcohol 70% Prep Pads

Principal Display PanelPrincipal Display Panel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-303-15EA - Each81902-303eb587660-e3fd-45d7-b983-3653344b0ddc12021-12-08
70512-014-30EA - Each70512-01479ff6a9e-984f-42ba-a2cc-130713989a4a12021-06-02

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81902-30381902-303-15
70512-014

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINE 4%SOLA Pharmaceuticalsc31957dd-edea-ce98-e053-2a95a90a9c2d2026-05-05WarningsExact identifier
ndc (product): 70512-014
eafae824-10d8-2b3f-e053-2a95a90acc812106893c-d736-421d-b038-cfedd12fe21b2022-10-14WarningsExact identifier
spl id: eafae824-10d8-2b3f-e053-2a95a90acc81
spl set id: 2106893c-d736-421d-b038-cfedd12fe21b

Reported adverse events (FAERS/openFDA)#

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