ZYLOTROL PAIN RELIEVING CREAM

Manufacturer
Whitestone Products LLC
Effective date
2022-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:52:36

Label at a glance#

ProductZYLOTROL PAIN RELIEVING
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Label contents#

Full prescribing information#

Active ingredients 

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4.0%

Menthol 1.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic, Anesthetic

INDICATIONS & USAGE SECTION

Uses

For temporarily relief of pain

WARNINGS SECTION

Warnings 

For external use only.

Ask a doctor before use if you have a heart condition.

Do not use •if you are allergic to any other type of numbing medicine •in large quantities, particularly over raw surfaces or blistered areas •on infections •on deep puncture wounds •if pregnant or breastfeeding.

When using this product •do not use over large skin areas •do not apply heat, bandages or plastic wrap to treated areas •do not use in or near the eyes •wash hands immediately after using.

Stop use and ask a doctor if •allergic reaction occurs •condition worsens or does not improve within 7 days •symptoms clear up and return within a few days •redness, irritation, swelling, pain or other symptoms begin or increase.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply generously up to 3 to 4 times daily. For use on adults and children 12 years and older. Children under 12 - ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf Juice*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Hypericum Perforatum (St. John's Wort) Flower/leaf/stem Extract, Glyceryl Stearate, Glycerin, Hydrogenated Polydecene, Isopropyl Palmitate, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate 60, Propanediol, Sodium Polyacrylate, Stearyl Alcohol, Tetrahydroxypropyl Ethylenediamine, Trideceth-6, Water.

*Certified Organic Ingredient - Mayacert Certifier

OTC - QUESTIONS SECTION

Questions?

(310) 320-0100

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

newnew

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-222-04GM - Gram81902-222875a8f20-0364-42b6-bb74-6f1c39370dcc12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81902-22281902-222-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
06f133b3-b5d1-1850-e063-6394a90a9ff43cb92aee-ce8e-447e-9c48-b6e9373c680d2023-10-05WarningsExact identifier
spl set id: 3cb92aee-ce8e-447e-9c48-b6e9373c680d

Reported adverse events (FAERS/openFDA)#

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