Active Ingredients And Purpose
OTC - PURPOSE SECTION
Earwax removal aid.
OTC - ACTIVE INGREDIENT SECTION
Carbamide Peroxide 6.5%
Earwax Removal Drops
- Manufacturer
- Humco Holding Group, Inc | Pharma Nobis, LLC
- Effective date
- 2023-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:04:40
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
For occasional use as an aid to soften, loosen and remove excessive earwax.
Warnings
WARNINGS SECTION
For External Use Only. Ask a doctor before use if you have: Ear drainage or discharge Ear pain, irritation, or rash in the ear Recently had ear surgery Dizziness An injury or perforation (hole) of the eadrum
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.
Other Label Information
INACTIVE INGREDIENT SECTION
Citric Acid Flavor Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Sodium Stannate Purified Water
CVS Label
Leader Label
Rite Aid Label
Label Images#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0395-9133-45 | Earwax Removal Drops | 1 in 1 CARTON | LIQUID | 1 | 5 | |
| 0395-9133-45 | Earwax Removal Drops | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | 5 | |
| 0395-9133-90 | Earwax Removal Drops | 15 mL in 1 CONTAINER | LIQUID | 15 | 5 | |
| 0395-9133-90 | Earwax Removal Drops | 1 in 1 CARTON | LIQUID | 1 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
- Earwax Removal Drops
- Carbamide Peroxide 6.5%
- HYDROGEN PEROXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0395-9133 | 0395-9133-90, 0395-9133-45 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SODIUM STANNATE | NJ7C1V83KG | IACT |
| SODIUM LAUROYL SARCOSINATE | 632GS99618 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
Complete SPL Sections#
INACTIVE INGREDIENT SECTION
Citric Acid Flavor Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Sodium Stannate Purified Water
OTC - PURPOSE SECTION
Earwax removal aid.
DOSAGE & ADMINISTRATION SECTION
Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
WARNINGS SECTION
For External Use Only. Ask a doctor before use if you have: Ear drainage or discharge Ear pain, irritation, or rash in the ear Recently had ear surgery Dizziness An injury or perforation (hole) of the eadrum
OTC - ACTIVE INGREDIENT SECTION
Carbamide Peroxide 6.5%
INDICATIONS & USAGE SECTION
For occasional use as an aid to soften, loosen and remove excessive earwax.