Zylotrol

Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2022-10-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:51:48

Label at a glance#

ProductZylotrol
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Lidocaine 4%

Menthol 4%

OTC - PURPOSE SECTION

Purpose
Analgesic
Analgesic

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • muscle strains
  • sprains
  • bruises
  • muscle soreness
  • muscle stiffness

WARNINGS SECTION

Warnings: For external use only. Keep out of reach of children. Packaging is not child resistant. If put in mouth, contact a Poison Control Center right away. Use only as directed. Read and follow all directions and warnings on this box.

OTC - DO NOT USE SECTION

Do not use:

  • near the eyes and mucous membranes
  • on open wounds, cuts, damaged or infected skin
  • at the same time as other topical analgesics
  • with a heating pad
  • on genitals
  • if patch pouch has been opened for 7 or more days

OTC - ASK DOCTOR SECTION

Before use, ask a doctor if:

  • you are allergic to any of the listed ingredients
  • you are pregnant or breastfeeding
  • you have high blood pressure, heart disease or kidney disease
  • you are taking a diuretic

OTC - WHEN USING SECTION

When using patches:

  • wash hands thoroughly after applying or removing patch
  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • condition worsens
  • rash, irritation or itching develops
  • symptoms 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.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults 18 years and older - apply patch to affected area 1 to 2 times daily or as directed by your physician. Clean and dry affected area. Open pouch, remove one patch and remove protective film. Apply to affected area and leave in place for 8 to 12 hours. Only use one patch at a time. Do not use more than 2 patches per day. Reseal pouch containing unused patches after each use. Not indicated for children under 18 years of age.

OTHER SAFETY INFORMATION

Avoid storing product in direct sunlight. Protect contents from excessive moisture. Store at 66 - 77°F (19 - 25°C)

INACTIVE INGREDIENT SECTION

Inctive ingredients

Acrylic adhesive

OTC - QUESTIONS SECTION

Questions: (310) 320-0100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-504-15EA - Each76420-504e412b6cd-2c70-4cea-bd47-94062d67347f12022-11-07
81902-130-15EA - Each81902-13053dced8d-bee2-4832-ab6f-336d15b5451c12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-50476420-504-15
81902-130

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
0706af17-d120-e89d-e063-6394a90ad61dead97a8e-da50-b6aa-e053-2a95a90a0a8b2023-10-06WarningsExact identifier
spl set id: ead97a8e-da50-b6aa-e053-2a95a90a0a8b

Reported adverse events (FAERS/openFDA)#

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