Ultra Lido Gel Patch

Manufacturer
Singular Dreamer, Ltd dba True Marker
Effective date
2024-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:55

Label at a glance#

ProductUltra Lido Gel Patch
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For temporary relief of pain.

Dosage and administration

Adult and children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin Apply 1 patch at a time to affected area, not more than 3 to 4 times daily 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 Ingredient                                                          Purposes

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.00% .....................................................Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain.

Warnings

WARNINGS SECTION

  • For External Use only
  • 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

When using this product:

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

Stop use and ask a doctor if:

  • Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering ● Condition worsens
    ● Symptoms persist for more than 7 days ● Symptoms clear up and occur again within a few days
  • If pregnant or breast-feeding, ask a health professional before use.
  • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

● Store at controlled room temperature 20° - 25°C (68° - 77°F)
● Avoid storing product in direct sunlight
● Protect product from excessive moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycol Stearate,
Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil,Phenoxyethanol,Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid,
Triethanolamine.

SPL UNCLASSIFIED SECTION

Questions or Comments
Call 1-(888) 811-2634

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83035-1137ULTRA LIDO GEL PATCH (LIDOCAINE) PATCH [SINGULAR DREAMER, LTD DBA TRUE MARKER]1Unmatched20240724_fb170a56-8ff6-4326-91c2-a67d385b866a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83035-1137-1EA - Each83035-1137d7d1add4-103c-40f3-a3f5-20f51d346b6a12024-10-04

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83035-113783035-1137-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
4351418d-fb30-67a0-e063-6394a90ac7a6fb170a56-8ff6-4326-91c2-a67d385b866a2025-11-11WarningsExact identifier
spl set id: fb170a56-8ff6-4326-91c2-a67d385b866a

Reported adverse events (FAERS/openFDA)#

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