Indications and uses
For occasional use as an aid to soften, loosen and remove excessive ear wax.
Ear Wax Removal Drops
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Effective date
- 2020-03-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:09:40
Label at a glance#
ProductEar Wax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure10 sections
Dosage and administration
• 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 earwax remaining after treatment may be removed by gently flushing the ear with warm wat...
Label contents#
Full prescribing information#
Active ingredient
Carbamide Peroxide, 6.5%
OTC - PURPOSE SECTION
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
- eardrainage, discharge, ear pain,irritation
- rashin the ear,or are dizzy
- injuryor perforation (hole) of the ear drum or after ear surgery
When using this product
- do not use for more than four days
- avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
- if excessive earwax remains after the use of this product, consult a doctor
Keep 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 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
- When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.
- Children under 12 years: consult a doctor.
Other information
- Protect from heat and direct sunlight
- Keep cap on bottle when not in use.
- Lot No. and EXP date: see label, bottom container or box.
- NDC 68788-7496-01 1 Bottle .5FL OZ
Relabeled by Preferred Pharmaceuticals, Inc.
Inactive ingredients
Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid
Principal Display Panel Bottle Label 0.5 FL OZ
Preferred Plus Pharmacy
Ear Wax Removal drops
Carbamide Peroxide 6.5%
0.5 FL OZ (15ml)
- NDC: 68788-7498-01 Bottle .5 FL OZ
Relabeled by Preferred Pharmaceuticals, Inc.
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-7498-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-3ca9-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-7498-1 | Ear Wax Removal Drops | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 | |
| 68788-7498-1 | Ear Wax Removal Drops | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7498 | EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE - 6.5%) SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20200505_b6e3ad1c-5134-49f2-8664-534635b9eec3.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-339-05 | ML - Milliliter | 57896-339 | 60f9d315-f236-4cbe-ba42-4d7e2bd5bcca | 1 | 2018-01-12 |
Products#
Every source-derived product name is available through these pages.
- Ear Wax Removal Drops
- Carbamide Peroxide - 6.5%
- CARBAMIDE PEROXIDE
- HYDROGEN PEROXIDE
- GLYCERIN
- ANHYDROUS CITRIC ACID
- PROPYLENE GLYCOL
- SODIUM CITRATE, UNSPECIFIED FORM
- SODIUM LAURYL SULFATE
- TARTARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68788-7498 | 68788-7498-1 |
| 57896-339 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| TARTARIC ACID | W4888I119H | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| Ear Wax Removal Drops | CARBAMIDE PEROXIDE - 6.5% | GeriCare Pharmaceutical Corp | 239702af-cf93-43ee-b1af-8e53642395c1 | 2025-12-09 | Warnings | 57896-339 |
| b6e3ad1c-5134-49f2-8664-534635b9eec3 | b6e3ad1c-5134-49f2-8664-534635b9eec3 | 2020-03-02 | Warnings | b6e3ad1c-5134-49f2-8664-534635b9eec3 b6e3ad1c-5134-49f2-8664-534635b9eec3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.