FOR USE IN 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 flushing the ear with warm wate...
Carbamide peroxide 6.5%
Earwax removal aid
For occasional use as an aid to soften, loosen and remove excessive earwax.
• avoid contact with eyes. If accidental contact with eyes occurs, flush
eyes with water and consult a doctor
If product is swallowed, get medical help or contact a Poison Control Center right away.
FOR USE IN 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
flushing the ear with warm water, using a soft rubber bulb.
Children under 12 years of age: consult a doctor
• do not store above 86ºF (30ºC)
• protect from heat and direct sunlight
• DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING
• Product foams on contact with earwax due to the release of oxygen. There may be an associated “crackling” sound.
• Keep cap on bottle when not in use
• Retain carton for full product information.
citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-488-68 | Carbamide peroxide 6.5% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 2 | |
| 69168-488-68 | Carbamide peroxide 6.5% | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69168-488 | 69168-488-68 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
| CITRIC ACID | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-10-28 | monthly-update | 2026-06-03 17:39:34 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Carbamide peroxide 6.5% | EARWAX REMOVAL KIT | Allegiant Health | 54515e9d-2225-4875-a1cf-a24a823300dd | 2025-10-28 | Warnings | 69168-488-68 69168-488 69168048868 4f1c9234-6bb1-4795-af84-731f628424db 54515e9d-2225-4875-a1cf-a24a823300dd |
Adverse event summaries are temporarily unavailable. Other product information remains available.