Active ingredient Purpose
Carbamide peroxide 6.5% Earwax removal aid
Carbamide peroxide 6.5% Earwax removal aid
For occasional use as an aid to soften, loosen and remove excessive earwax
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 4 consecutive
days; if excessive earwax remains after use of this
product, consult a doctor
When using this product • avoid contact with eyes.
If accidental contact with eyes occurs, flush eyes
with water and consult a doctor
Keep out of reach of the children
If product is 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 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 the 4-day 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 |
|---|---|---|---|---|---|
| 49035-537-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f394-f424-e053-dadaa90a57ce | Drug Facts 25-119PQ |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-537-01 | Earwax Removal DropsEquate | 1 in 1 CARTON | LIQUID | 1 | 3 | |
| 49035-537-01 | Earwax Removal DropsEquate | 15 mL in 1 BOTTLE | LIQUID | 15 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49035-537 | 49035-537-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM LAUROYL SARCOSINATE | 632GS99618 | IACT |
| SODIUM STANNATE | NJ7C1V83KG | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 618083ab-73e1-1a00-e053-2a91aa0a1ccd | 4b601252-9b3b-4022-83b4-ca437254e4d9 | 2017-12-29 | Warnings | 618083ab-73e1-1a00-e053-2a91aa0a1ccd 4b601252-9b3b-4022-83b4-ca437254e4d9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.