SPL v1
SPL
SPL Set ID 4265361b-5526-c3e0-e063-6394a90a1777
Route
TOPICAL
Published
Effective Date 2025-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Glycerin Alcohol Bisabolol Zingiber Officinale (ginger) Root Oil Aloe Vera Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-03

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 degress 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

When using this product

  • 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

Stop use and ask a doctor if

  • rash or irritation develops
  • symptoms worsen or persist for more than 7 days or clear up and occur again within a few days
Indications and Usage

For the temporary relief of pain

Dosage and Administration

Lidocaine HCl 4%

Topical anesthetic

Description

Lidocaine HCl 4%

Section 50565-1

Directions

  • adults and chilren 2 years of age and older: apply 2 to 3 drops 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 50567-7
  • Use only as directed. Read and follow all directions and warning on this label
  • do not allow contact wtih the eyes and mucous membranes
  • do not use with other topical analgesics
Section 51727-6

alcohol

aloe barbadensis leaf juice

bisabolol

glycerin

isopropyl alcohol

maltodextrin

water

zingiber officinale (ginger) root extract

Section 51945-4

Lipo #1 ENT Doctor Recommended

Ear Pain Relief Drops

Kids with 4% Lidocaine

for fast acting earache pain relief, plus:

  • Soothe discomfort, swelling, and pressure
  • Helps fight harmful bacteria

EAR DROPS 0.42 FL OZ (12.4mL)

Enhanced Formula max strength pain relief, plus

Helps fight harmful bacteria

Helps dry & relieve water-clogged ears

Gently helps flush ear wax and debris

FAST ACTING PAIN RELIEF

Quickly Numbs Pain

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 storing

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

Distributed by: Lipo Flavonoid LLC

811 Broad Street, Suite 600

Chattanooga, TN 37402

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 degress 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

When using this product

  • 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

Stop use and ask a doctor if

  • rash or irritation develops
  • symptoms worsen or persist for more than 7 days or clear up and occur again within a few days
Section 50565-1 (50565-1)

Directions

  • adults and chilren 2 years of age and older: apply 2 to 3 drops 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 50567-7 (50567-7)
  • Use only as directed. Read and follow all directions and warning on this label
  • do not allow contact wtih the eyes and mucous membranes
  • do not use with other topical analgesics
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)

Lipo #1 ENT Doctor Recommended

Ear Pain Relief Drops

Kids with 4% Lidocaine

for fast acting earache pain relief, plus:

  • Soothe discomfort, swelling, and pressure
  • Helps fight harmful bacteria

EAR DROPS 0.42 FL OZ (12.4mL)

Enhanced Formula max strength pain relief, plus

Helps fight harmful bacteria

Helps dry & relieve water-clogged ears

Gently helps flush ear wax and debris

FAST ACTING PAIN RELIEF

Quickly Numbs Pain

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 storing

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

Distributed by: Lipo Flavonoid LLC

811 Broad Street, Suite 600

Chattanooga, TN 37402

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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