Indications and uses
For occasional use as an aid to soften, loosen and remove excessive ear wax.
Wax B Gone Ear Wax Removal Drops
- Manufacturer
- SIGMAR, LLC
- Effective date
- 2024-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:06:53
Label at a glance#
ProductWax B Gone Ear Wax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure12 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 water, using a ...
Label contents#
Full prescribing information#
Active ingredient
Carbamide Peroxide, 6.5%
Purpose
Earwax Removal Aid
Uses
For occasional use as an aid to soften, loosen and remove excessive ear wax.
Warnings
Ask a Doctor before use if you have
- eardrainage, discharge,
- ear pain
- irritation or rash in the ear
- dizziness
- injury or perforation (hole) of the ear drum
- recently had ear surgery
Stop Use and ask a Doctor if
- you need to use for more than 4 days
- execessive ear wax remain after use of this product
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
- product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
- Keep cap on bottle when not in use.
- Lot No. and EXP date: see label, bottom container or box.
Inactive ingredients
Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid
Principal Display Panel Bottle Label 0.5 FL OZ
Wax B Gone NDC 82498-149-15
Ear Wax Removal drops
Carbamide Peroxide 6.5%
0.5 FL OZ (15ml)
Principal Display Panel - Carton label 0.5 FL OZ
Wax B Gone NDC 82498-149-15
Ear wax Remover Drops
Carbamide Peroxide 6.5%
Ear wax removal aid
0.5 FL OZ ( 15ml)
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82498-149-15 | Wax B Gone Ear Wax Removal Drops | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 2 | |
| 82498-149-15 | Wax B Gone Ear Wax Removal Drops | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Wax B Gone Ear Wax Removal Drops
- Carbamide Peroxide - 6.5%
- CARBAMIDE PEROXIDE
- HYDROGEN PEROXIDE
- GLYCERIN
- ANHYDROUS CITRIC ACID
- PROPYLENE GLYCOL
- SODIUM CITRATE
- SODIUM LAURYL SULFATE
- TARTARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82498-149 | 82498-149-15 |
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 | 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 |
|---|---|---|---|---|---|---|
| Wax B Gone Ear Wax Removal Drops | CARBAMIDE PEROXIDE - 6.5% | SIGMAR, LLC | 3339cac0-8f32-4f71-bef3-dd1524c4b244 | 2024-01-08 | Warnings | 82498-149-15 82498-149 82498014915 e1c35778-377e-44e8-9681-9dee84b04723 3339cac0-8f32-4f71-bef3-dd1524c4b244 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.