Indications and uses
for occasional use as an aid to soften, loosen and remove excessive ear wax
for occasional use as an aid to soften, loosen and remove excessive ear wax
Active ingredient Purpose
Carbamide Peroxide 6.5%......................................................Earwax removal aid
for occasional use as an aid to soften, loosen and remove excessive ear wax
Warnings
Ask a doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in the ear • dizziness• an injury or perforation (hole) of the eardrum • recently had ear surgery
When using this product avoid contact with the eyes
Stop use and ask a doctor if • you need to use for more than four days • excessive ear wax remains after use of this product
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
FOR USE IN THE EAR ONLY
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 the ear with warm water, using a soft rubber bulb ear syringe children under 12 years: consult a doctor
Inactive ingredients
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-041-07 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1da0-f424-e053-dadaa90a57ce | 5a910721-4b33-42f0-b35c-7eea8f7d1898 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-040-01 | EARWAX REMCVS | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 mL | 6.5 g in 100mL | 2 |
| 69842-041-07 | EARWAX REMCVS | 1 in 1 KIT | KIT | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69842-040 | EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS] | 2 | Unmatched | 20171120_5a910721-4b33-42f0-b35c-7eea8f7d1898.zip |
| 69842-041 | EARWAX REM CVS (CARBAMIDE PEROXIDE 6.50%) KIT [CVS] | 2 | Legacy NDC, 2 package rows | 20171120_5a910721-4b33-42f0-b35c-7eea8f7d1898.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-040 | 69842-040-01 |
| 69842-041 | 69842-041-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Carbamide Peroxide | 31PZ2VAU81 | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CHAMOMILE | FGL3685T2X | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Oxyquinoline Sulfate | 61VUG75Y3P | IACT |
| MINERAL OIL | T5L8T28FGP | 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 |
|---|---|---|---|---|---|---|
| 0dc97168-281b-4187-a54a-67eab90d5e3b | 5a910721-4b33-42f0-b35c-7eea8f7d1898 | 2017-11-20 | Warnings | 0dc97168-281b-4187-a54a-67eab90d5e3b 5a910721-4b33-42f0-b35c-7eea8f7d1898 |
Adverse event summaries are temporarily unavailable. Other product information remains available.