Otc - Active Ingredient
Lidocaine HCl 4%
Lipoflavonoid Ear Pain Kids Relief Drops Liquid
FDA Label NDC 69693-902
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clarion Brands Llc for the product Lipoflavonoid Ear Pain Kids Relief Drops (NDC 69693-902). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, inactive ingredient, otc - questions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical anesthetic
Indications & Usage
For the temporary relief of pain
Warnings
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
- 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
- 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
- rash or irritation develops
- symptoms worsen or persist for more than 7 days or clear up and occur again within a few days
Do not use
When using this product
Stop use and ask a doctor if
Otc - When Using
- 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
Inactive Ingredient
alcohol
aloe barbadensis leaf juice
bisabolol
glycerin
isopropyl alcohol
maltodextrin
water
zingiber officinale (ginger) root extract
Otc - Questions
call 1-844-454-7632
Dosage & Administration
Lidocaine HCl 4%
Topical anesthetic
Otc - Keep Out Of Reach Of Children
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
Package Label.Principal Display Panel
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
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