FDA.reportPublic FDA data

Freskaro Earwax Removal Kit

Manufacturer
Pharma Nobis, LLC
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:53:53

Label at a glance#

ProductFreskaro Earwax Removal Aid
Active ingredientCARBAMIDE PEROXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

OTC - PURPOSE SECTION

Earwax removal aid

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen, and remove excessive earwax.

Do not use

WARNINGS SECTION

  • if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor
  • if you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor
  • for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • excessive earwax remains after use of this product for 4 consecutive days.

INACTIVE INGREDIENT SECTION

Citric acid

Flavor

Glycerin

Propylene Glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified Water

DOSAGE & ADMINISTRATION SECTION

  • FOR USE IN THE EAR ONLY. Remove any hearing aids before use.
  • Adults and children over 12 years of age:
  • ​tilt head sideways
  • place 5 to 10 drops into ear
  • tip of applicator should not enter ear canal
  • keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
  • use twice daily for up to four days if needed, or as directed by a doctor
  • any wax remaining after treatment may be removed by gently flushing ear with warm (body temperature) water, using a soft rubber bulb ear syringe
  • Children under 12 years of age: Consult a physician

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Earwax Removal Kit 2026Freskaro Earwax Removal Kit 2026Freskaro Earwax Removal CartonFreskaro Earwax Removal CartonFreskaro Earwax Removal BottleFreskaro Earwax Removal Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN2
702050carbamide peroxide 65 MG/ML Otic SolutionSCD2
702050carbamide peroxide 6.5 % Otic SolutionSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382645097905GTIN-13: 0382645097905
EAN-13: 0382645097905
GTIN-12: 382645097905
UPC-A: 382645097905
GTIN storage (14 digits): 00382645097905		Freskaro Earwax Removal Carton 4 13 2026.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-097-45Freskaro Earwax Removal Aid1 in 1 CARTONLIQUID12
82645-097-45Freskaro Earwax Removal Aid15 mL in 1 BOTTLE, DROPPERLIQUID152
82645-097-90Freskaro Earwax Removal Aid1 in 1 CARTONLIQUID12
82645-097-90Freskaro Earwax Removal Aid15 mL in 1 BOTTLE, DROPPERLIQUID152

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82645-09782645-097-90, 82645-097-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAUROYL SARCOSINATE632GS99618IACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM STANNATENJ7C1V83KGIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

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
Freskaro Earwax Removal AidCARBAMIDE PEROXIDE 6.50% KITPharma Nobis, LLC4f5967ee-bc05-341c-e063-6394a90a35c62026-04-15WarningsExact identifier
ndc (package): 82645-097-90
ndc (package): 82645-097-45
ndc (product): 82645-097
ndc11 (package): 82645009745
ndc11 (package): 82645009790
spl id: 4f86b363-aff6-1bfb-e063-6394a90a317f
spl set id: 4f5967ee-bc05-341c-e063-6394a90a35c6

Reported adverse events (FAERS/openFDA)#

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