SPL v1
SPL
SPL Set ID 2d7e9f6a-0f21-b103-e063-6294a90a912f
Route
AURICULAR (OTIC)
Published
Effective Date 2025-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Bisabolol Zingiber Officinale (ginger) Root Oil Water Maltodextrin Glycerin Alcohol Isopropyl Alcohol Aloe Barbadensis Leaf

Identifiers & Packaging

Pill Appearance
Shape: round
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-17

Description

Lidocaine HCl 4%


Medication Information

Warnings and Precautions

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
Indications and Usage
  • for the temporary relief of pain
Dosage and Administration

Lidocaine HCl 4%

Topical anesthetic

Description

Lidocaine HCl 4%

Section 50565-1

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

Section 50567-7
  • 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
Section 50569-3

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

Section 51727-6

alcohol

aloe barbadensis leaf juice

bisabolol, glycerin

isopropyl alcohol

maltodextrin

water

zingiber officinale (ginger) root extract

Section 51945-4

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

Section 53413-1

call 1-844-454-7632

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine HCl 4%


Structured Label Content

Indications and Usage (34067-9)
  • for the temporary relief of pain
Dosage and Administration (34068-7)

Lidocaine HCl 4%

Topical anesthetic

Warnings and Precautions (34071-1)

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
Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)
  • 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
Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

alcohol

aloe barbadensis leaf juice

bisabolol, glycerin

isopropyl alcohol

maltodextrin

water

zingiber officinale (ginger) root extract

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

call 1-844-454-7632

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine HCl 4%


Advanced Ingredient Data


Raw Label Data

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