FDA.reportPublic FDA data

Ultra Lido Cream

Manufacturer
Singular Dreamer, Ltd dba True Marker
Effective date
2025-05-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:38:55

Label at a glance#

ProductUltra Lido Cream
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

For the temporary relief of pain and itching, associated with minor burns, sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consults a doctor.

Label contents#

Full prescribing information#

Active Ingredient                                                          Purposes

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.00% .....................................................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching, associated with minor burns, sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Warnings

WARNINGS SECTION

  • For External Use only
  • Avoid contact with the eyes.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • Stop Use and Ask a Doctor ifcondition worsens or if symptoms persist for more than 7 days
    or occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use,
consults a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature, 20 – 25°C (68-77°F).

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.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83035-1138ULTRA LIDO CREAM (LIDOCAINE) CREAM [SINGULAR DREAMER, LTD DBA TRUE MARKER]2Unmatched20250521_0cae1458-604d-448e-a803-b4338a91c263.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83035-1138-6GM - Gram83035-11387ea127db-6b5d-4a57-806c-188c70b9b2b212024-09-09

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83035-113883035-1138-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCOL STEARATE0324G66D0EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER OIL3W1JG795YIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT
JOJOBA OIL724GKU717MIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

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
3582c177-1f60-7de2-e063-6294a90a4e720cae1458-604d-448e-a803-b4338a91c2632025-05-19WarningsExact identifier
spl id: 3582c177-1f60-7de2-e063-6294a90a4e72
spl set id: 0cae1458-604d-448e-a803-b4338a91c263

Reported adverse events (FAERS/openFDA)#

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