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#
Contacts and useful links#
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76420-504-15 | EA - Each | 76420-504 | e412b6cd-2c70-4cea-bd47-94062d67347f | 1 | 2022-11-07 |
| 81902-130-15 | EA - Each | 81902-130 | 53dced8d-bee2-4832-ab6f-336d15b5451c | 1 | 2022-11-07 |
Products#
Every source-derived product name is available through these pages.
- Zylotrol
- Lidocaine 4%, Menthol 4%
- ACRYLIC ACID
- LIDOCAINE
- MENTHOL, UNSPECIFIED FORM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76420-504 | 76420-504-15 |
| 81902-130 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACRYLIC ACID | J94PBK7X8S | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0706af17-d120-e89d-e063-6394a90ad61d | ead97a8e-da50-b6aa-e053-2a95a90a0a8b | 2023-10-06 | Warnings | ead97a8e-da50-b6aa-e053-2a95a90a0a8b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
