FDA.reportPublic FDA data

Zylotrol Plus

Manufacturer
Whitestone Products LLC
Effective date
2021-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:32:20

Label at a glance#

ProductZylotrol Plus
Active ingredientLIDOCAINE, MENTHOL, ISOPROPYL ALCOHOL
Label structure15 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches / day. Leave patch on affected area for up to 8 hours Do not use patches for longer than five consecutive days, Children under 12 should consult physician prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.00%

Menthol 1.00%

OTC - PURPOSE SECTION

Topical Anesthetic

External Analgesic

USES:

INDICATIONS & USAGE SECTION

For temporary relief of pain

WARNINGS:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do not use

OTC - DO NOT USE SECTION

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

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 (Adults and Children Over 12 Years):

DOSAGE & ADMINISTRATION SECTION

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8 hours

Do not use patches for longer than five consecutive days,

Children under 12 should consult physician prior to use.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

SPL UNCLASSIFIED SECTION

Store below 25 degrees Celsius, Avoid directe sunlight.

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: 81902-202-15

Zylotrol TM Plus

Pacakge Contains:

15 Lidocaine 4%/ Menthol 1% Topical Analgesic 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
81902-202-15EA - Each81902-202464c007e-63bf-4126-bd69-3387669f905812021-12-08

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81902-20281902-202-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 806OZP39ZG8HIACT
TARTARIC ACIDW4888I119HIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
METHYLPARABENA2I8C7HI9TIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
06f11d1a-812e-97d6-e063-6294a90af03138bad3dd-cdaf-47a9-bbce-0a7b024924882023-10-05WarningsExact identifier
spl set id: 38bad3dd-cdaf-47a9-bbce-0a7b02492488

Reported adverse events (FAERS/openFDA)#

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