OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Carbamide Peroxide 6.5%............................Earwax removal aid
Active ingredient Purpose
Carbamide Peroxide 6.5%............................Earwax removal aid
Uses
For occasional use as an aid to soften, loosen, and
remove excessive ear wax
Warnings
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 ear drum or after
ear surgery unless directed by a doctor. • for more than four
consecutive days.
When using this product • avoid contact with eyes
Stop use and ask a doctor if • excessive ear wax remains
after use of this product for four consecutive days
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away. If accidental contact
with eyes occurs, flush eyes with water and consult a doctor.
Directions 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 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 of age: consult a doctor
Other information
Protect from heat and direct sunlight.
Keep cap on bottle when not in use
Inactive ingredients
Aloe Barbadensis Leaf Extract,
Chamomilla Recutita (Matricaria) Flower Extract, Glycerin,
Mineral Oil, Oxyquinoline Sulfate, Water.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64048-5118-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-df46-f424-e053-dadaa90a57ce | abfbf016-fda2-44a3-8bd7-be5eb9cd8b99 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64048-5118-1 | Ear Wax Removal Drops | 15 mL in 1 BOTTLE | LIQUID | 15 | 1 | |
| 64048-5118-1 | Ear Wax Removal Drops | 1 in 1 CARTON | LIQUID | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64048-5118 | EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [PRODUCT QUEST MFG] | 1 | Legacy NDC, 2 package rows | 20180817_abfbf016-fda2-44a3-8bd7-be5eb9cd8b99.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 64048-5118 | 64048-5118-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Carbamide Peroxide | 31PZ2VAU81 | ACTIB |
| Aloe | V5VD430YW9 | IACT |
| CHAMOMILE | FGL3685T2X | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Mineral Oil | T5L8T28FGP | IACT |
| Oxyquinoline Sulfate | 61VUG75Y3P | 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 |
|---|---|---|---|---|---|---|
| f2c3033a-b17f-4cd6-97c2-d5f4d204da63 | abfbf016-fda2-44a3-8bd7-be5eb9cd8b99 | 2018-08-16 | Warnings | f2c3033a-b17f-4cd6-97c2-d5f4d204da63 abfbf016-fda2-44a3-8bd7-be5eb9cd8b99 |
Adverse event summaries are temporarily unavailable. Other product information remains available.