Indications and uses
For occasional use as an aid to soften, loosen and remove excessive earwax
For occasional use as an aid to soften, loosen and remove excessive earwax
Carbamide peroxide 6.5% Earwax removal aid
For occasional use as an aid to soften, loosen and remove excessive earwax
Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery
When using this product avoid contact with eyes
Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product
Stop use and ask a doctor if you need to use for more than four days • excessive earwax remains after use of this product
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
DirectionsFor 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 flushing the ear with warm water, using a soft rubber bulb ear syringe
Children under 12 years of age: consult a doctor.
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-039-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-16d8-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-039-01 | EAR WAX RMVLCVS | 1 in 1 CARTON | LIQUID | 1 | 2 | |
| 69842-039-01 | EAR WAX RMVLCVS | 15 mL in 1 BOTTLE | LIQUID | 15 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-039 | 69842-039-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Carbamide Peroxide | 31PZ2VAU81 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Sodium Lauroyl Sarcosinate | 632GS99618 | IACT |
| Sodium Stannate | NJ7C1V83KG | IACT |
| Water | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| 5e49a43a-a39c-44e1-a373-187d52d26d10 | 6d677dc4-3c05-451f-9918-33323667cc90 | 2017-11-20 | Warnings | 5e49a43a-a39c-44e1-a373-187d52d26d10 6d677dc4-3c05-451f-9918-33323667cc90 |
Adverse event summaries are temporarily unavailable. Other product information remains available.