FDA.reportPublic FDA data

LidoER

Manufacturer
Diabetic Supply of Suncoast, Inc. | Pharma Supply, Inc.
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:46:32

Label at a glance#

ProductLidoER
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

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: consult a doctor

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Lidocaine HCL 4%............................Topical analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces, or blistered areas.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact a Poison Control Center immediately.

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: consult a doctor

Other information

OTHER SAFETY INFORMATION

▪ store in a cool dry place between (59-86°F)15-30°C

▪ don’t use if seal over cap is broken, torn, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

c9-11 alkane/cycloalkane, cetostearyl alcohol, imidurea, menthol, methylparaben, mineral oil, peg-150 stearate, petrolatum, polysorbate 60, propylene glycol, propylparaben, steareth-20, stearic acid, trideceth-12, water

Questions or comments?

OTC - QUESTIONS SECTION

(M-F) +1-888-469-3579

  • Advocatemeters.com

Distributed by:

SPL UNCLASSIFIED SECTION

Diabetic Supply of Suncoast, Inc.

PO Box 2102, Vega Alta, PR 00692

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidoERLidoER

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71814-12171814-121-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AIACT
PEG-150 STEARATE7BSG7DF10QIACT
PETROLATUM4T6H12BN9UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
STEARETH-20L0Q8IK9E08IACT
STEARIC ACID4ELV7Z65APIACT
PROPYLPARABENZ8IX2SC1OHIACT
TRIDECETH-12YFY3KG5Y7OIACT
WATER059QF0KO0RIACT
C9-11 ALKANE/CYCLOALKANE3EZ541F5MWIACT
IMIDUREAM629807ATLIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
ee279fc1-02f6-2d5f-e053-2995a90aeedcaf4d337f-4f79-14c5-e053-2a95a90afb952022-11-23WarningsExact identifier
spl id: ee279fc1-02f6-2d5f-e053-2995a90aeedc
spl set id: af4d337f-4f79-14c5-e053-2a95a90afb95

Reported adverse events (FAERS/openFDA)#

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