Indications and uses
For occasional use as an aid soften, loosen, and remove excessive ear wax
For occasional use as an aid soften, loosen, and remove excessive ear wax
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 r...
Carbamide Peroxide 6.5% Softens & removes wax
For occasional use as an aid soften, loosen, and remove excessive ear wax
Do not use
• If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor.
• If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor.
When using this product avoid contact with eyes
Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.
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.
Glyceryn, Oxyquinoline
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24385-501-07 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7858-f424-e053-dadaa90a57ce | EarWax Removal Drops Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24385-500-01 | Ear SystemGNP | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 mL | 6.5 g in 100mL | 2 |
| 24385-501-07 | Ear SystemGNP | 1 in 1 KIT | KIT | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 24385-500 | EAR SYSTEM GNP (CARBAMIDE PEROXIDE 6.50%) KIT [AMERISOURCE BERGEN] | 2 | Unmatched | 20160505_b326b175-e792-44ed-a68c-9aa587bb717c.zip |
| 24385-501 | EAR SYSTEM GNP (CARBAMIDE PEROXIDE 6.50%) KIT [AMERISOURCE BERGEN] | 2 | Legacy NDC, 2 package rows | 20160505_b326b175-e792-44ed-a68c-9aa587bb717c.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 24385-500 | 24385-500-01 |
| 24385-501 | 24385-501-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Carbamide Peroxide | 31PZ2VAU81 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| OXYQUINOLINE SULFATE | 61VUG75Y3P | 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 |
|---|---|---|---|---|---|---|
| 664ed3d6-89c2-4336-a34f-d9553ab35cc9 | b326b175-e792-44ed-a68c-9aa587bb717c | 2016-05-04 | Warnings | 664ed3d6-89c2-4336-a34f-d9553ab35cc9 b326b175-e792-44ed-a68c-9aa587bb717c |
Adverse event summaries are temporarily unavailable. Other product information remains available.