FDA.reportPublic FDA data

Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine

Manufacturer
Clarion Brands LLC
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:50

Label at a glance#

ProductLipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain

WARNINGS SECTION

For external use only

Flammable

  • keep away from fire, sparks, and heated surfaces
  • exposure to temperatures above 130°F may cause bursting
  • store at room temperature in a dry place

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas
  • for more than one week without consulting a doctor
  • if you have a hole in your ear drum or tubes in your ear

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warning on this label
  • do not allow contact with the eyes and mucous membranes
  • do not use with other topical analgesics

Directions

  • adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • this package is child-resistant

INACTIVE INGREDIENT SECTION

alcohol

aloe barbadensis leaf juice

bisabolol, glycerin

isopropyl alcohol

maltodextrin

water

zingiber officinale (ginger) root extract

OTC - QUESTIONS SECTION

call 1-844-454-7632

DOSAGE & ADMINISTRATION SECTION

Lidocaine HCl 4%

Topical anesthetic

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

■ rash or irritation develops

■ if symptoms worsen or 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 Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

LipoFlavonoid ®

#1 ENT DOCTOR RECOMMENDED †

EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE

for fast acting earache pain relief, plus:

  • Soothe discomfort, swelling, and pressure
  • Helps fight harmful bacteria
  • Swimmers Ear, Cold & Flu, Allergies *

FAST ACTING PAIN RELIEF

EAR DROPS 0.42 FL OZ (12.4 mL)

SAFE & EFFECTIVE FOR CHILDREN 2 years old and up

Consult your doctor before using on children under 2 years old.

DIRECTIONS:

  • Tilt head and apply 2 to 3 drops into affected ear
  • Hold position for 1 minute
  • Repeat no more than 4 times per day
  • Keep child proof cap tightly closed when stroring

DO NOT USE if you have a hole in your ear drum or tubes in your ear.

Distributed by: Lipo Flavonoid LLC

811 Broad Street, Suite 600

Chattanooga, TN 37402 ©2025

ENHANCED FORMULA max strength pain relief, plus

Helps fight harmful bacteria

Quickly dry & relieve water-clogged ears

Gently helps flush ear wax and debris

*relief from earaches due to swimming, cold & flu, and allergies

†data on file

Lipoflavonoid Ear Pain Relief DropsLipoflavonoid Ear Pain Relief Drops

Lipoflavonoid Ear Pain Relief DropsLipoflavonoid Ear Pain Relief Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2595042lidocaine HCl 4 % Otic SolutionPSN1
2595042lidocaine hydrochloride 40 MG/ML Otic SolutionSCD1
2595042lidocaine hydrochloride 4 % Otic SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-901-04Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine12.4 mL in 1 BOTTLE, DROPPERLIQUID12.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69693-901LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE LIQUID [CLARION BRANDS LLC]1Current NDC, 1 package rows20250226_2d7e9f6a-0f21-b103-e063-6294a90a912f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69693-90169693-901-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISABOLOL24WE03BX2TIACT
ZINGIBER OFFICINALE (GINGER) ROOT OILSAS9Z1SVUKIACT
WATER059QF0KO0RIACT
MALTODEXTRIN7CVR7L4A2DIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT

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
Lipo Flavonoid Ear Pain Relief Drops with 4% LidocaineLIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINEClarion Brands LLC2d7e9f6a-0f21-b103-e063-6294a90a912f2025-02-06WarningsExact identifier
ndc (package): 69693-901-04
ndc (product): 69693-901
ndc11 (package): 69693090104
spl id: 2d7e9f6a-0f22-b103-e063-6294a90a912f
spl set id: 2d7e9f6a-0f21-b103-e063-6294a90a912f

Reported adverse events (FAERS/openFDA)#

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