Family Care Earwax Removal Aid Drops 0.5 oz 639 ZDP

Manufacturer
United Exchange Corp.
Effective date
2025-10-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:40:23

Label at a glance#

ProductFamily Care Earwax Removal
Active ingredientCARBAMIDE PEROXIDE
Label structure11 sections

Storage and handling

Other information do not store above 25°C (77°F) store bottle in the outer carton product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound keep cap on bottle when not in use

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Carbamide peroxide 6.5%.................................Ear wax removal

OTC - PURPOSE SECTION

Uses

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

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • dizziness
  • irritation or rash in the ear
  • recently had ear surgery
  • an injury or perforation (hole) of the eardrum

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you need to use for more than four days
  • excessive earwax remains after use of this product

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

FOR USE IN THE EAR ONLY

  • adults and children over 12 years of age:
  • tilt head sideways and 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 ear
  • use twice daily for up to four days if needed, or as directed by a doctor
  • any way remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
  • children under 12 years: consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • do not store above 25°C (77°F)
  • store bottle in the outer carton
  • product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound
  • keep cap on bottle when not in use

INACTIVE INGREDIENT SECTION

Inactive ingredients

citric acid monohydrate, flavor, glycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, sodium stannate

DOSAGE & ADMINISTRATION SECTION

Distributed by:

United Exchange Corp.

Cypress, CA 90630

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

639.1639.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN4
702050carbamide peroxide 65 MG/ML Otic SolutionSCD4
702050carbamide peroxide 6.5 % Otic SolutionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130780707006399GTIN-13: 0780707006399
EAN-13: 0780707006399
GTIN-12: 780707006399
UPC-A: 780707006399
GTIN storage (14 digits): 00780707006399
639.jpg

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-639-15Family Care Earwax Removal15 mL in 1 BOTTLE, DROPPERLIQUID154
65923-639-15Family Care Earwax Removal1 in 1 CARTONLIQUID14

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-63965923-639-15

Ingredients#

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

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

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-24full-release2026-06-01 00:48:42

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
Family Care Earwax RemovalCARBAMIDE PEROXIDEUnited Exchange Corp.958741f5-47c1-339c-e053-2a95a90a3f5f2025-10-22WarningsExact identifier
ndc (package): 65923-639-15
ndc (product): 65923-639
ndc11 (package): 65923063915
spl id: 41c7b5be-d04d-cad3-e063-6294a90ae421
spl set id: 958741f5-47c1-339c-e053-2a95a90a3f5f

Reported adverse events (FAERS/openFDA)#

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