FDA.reportPublic FDA data

Family Wellness Earwax Removal Earwax and Bulb

Manufacturer
Family Dollar Services Inc | Bell Pharmaceuticals, Inc.
Effective date
2025-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:25

Label at a glance#

ProductFamily Wellness Earwax Removal Earwax and Bulb
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

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 the ear Use twice daily for up to 4 days if needed, or as directed by a doctor Any wax remaining after treatment may be removed by gently flusing the ear with warm water,...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For use in the ear only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • you need to use for more than 4 days
  • excessive earwax remains after use of this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 the ear
  • Use twice daily for up to 4 days if needed, or as directed by a doctor
  • Any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe

Children under 12 years:consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Do not store above 25°C (77°F)
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

OTC - QUESTIONS SECTION

1-800-328-5890

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN3
702050carbamide peroxide 65 MG/ML Otic SolutionSCD3
702050carbamide peroxide 6.5 % Otic SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-835-01Family Wellness Earwax Removal Earwax and Bulb1 in 1 KITKIT13
55319-836-01Family Wellness Earwax Removal Earwax and Bulb1 in 1 BOXSOLUTION/ DROPS65 mg in 1mL3
55319-836-01Family Wellness Earwax Removal Earwax and Bulb15 mL in 1 PACKAGESOLUTION/ DROPS15 mL65 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-835FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB (CARBAMIDE PEROXIDE) KIT [FAMILY DOLLAR SERVICES INC]3Current NDC, Legacy NDC, 3 package rows20250303_26ebf208-4710-4af2-aa2d-b2040b85cf85.zip
55319-836FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB (CARBAMIDE PEROXIDE) KIT [FAMILY DOLLAR SERVICES INC]3Unmatched20250303_26ebf208-4710-4af2-aa2d-b2040b85cf85.zip

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
55319-83555319-835-01
55319-83655319-836-01

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
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
Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDEFamily Dollar Services Inc26ebf208-4710-4af2-aa2d-b2040b85cf852025-02-28WarningsExact identifier
ndc (package): 55319-836-01
ndc (package): 55319-835-01
ndc (product): 55319-835
ndc11 (package): 55319083601
ndc11 (package): 55319083501
spl id: 2f39b7a8-7ec6-6d43-e063-6394a90ab983
spl set id: 26ebf208-4710-4af2-aa2d-b2040b85cf85

Reported adverse events (FAERS/openFDA)#

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