FDA.reportPublic FDA data

Earwax Treatment Drops

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2018-05-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:58:02

Label at a glance#

ProductEarwax Treatment Drops
Active ingredientCarbamide Peroxide
Label structure11 sections

Indications and uses

for occasional use as an aid to • soften • loosen • remove excessive ear wax

Dosage and administration

for adults and children 12 years and over, or as directed by a doctor: • 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 4 days if needed • use a soft, rubber bulb ear syringe to gently flush ear with warm water to remove any wax remaining after t...

Storage and handling

• store at 20°-25°C • avoid exposure to excessive heat and direct sunlight • keep tightly closed • see carton or label for lot number and expiration date. • TAMPER-EVIDENT: Do not use this product if the imprinted platic seal around the cap of the bottle is cut, torn, broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Ear wax removal aid

Uses

INDICATIONS & USAGE SECTION

for occasional use as an aid to

  • soften
  • loosen
  • remove excessive ear wax

Warnings

WARNINGS SECTION

For use in the ear only

OTC - DO NOT USE SECTION

Do not use this product, unless directed by a doctor

  • if you have an injury or perforation (hole) of the ear drum
  • after ear surgery
  • for more than 4 days

Ask your doctor before use if you

OTC - ASK DOCTOR SECTION

  • have ear drainage or discharge
  • have ear pain, irritation or rash in the ear
  • feel dizzy

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

for adults and children 12 years and over, or as directed by a doctor:

  • 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 4 days if needed
  • use a soft, rubber bulb ear syringe to gently flush ear with warm water to remove any wax remaining after treatment

Children under 12 years, consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C
  • avoid exposure to excessive heat and direct sunlight
  • keep tightly closed
  • see carton or label for lot number and expiration date.
  • TAMPER-EVIDENT: Do not use this product if the imprinted platic seal around the cap of the bottle is cut, torn, broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, glycerine, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate dihydrate, triethanolamine

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX®*

Rugby ®

NDC 68788-6439-1

TAMPER EVIDENT

Earwax
Treatment
Drops

Carbamide Peroxide 6.5%

Helps Remove
Excessive Earwax

1/2 fl oz (15 mL)

Repackaged By: Preferred Pharmaceuticals Inc.

Ear Drops Carbamide Peroxide 6.5 percent
Ear Drops Carbamide Peroxide 6.5 percent

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-6439-12020-11-10C16284748780-19d75b9cf-ce12-f424-e053-dadaa90a57ceEarwax Treatment Drops
68788-6439-12020-01-31C16284748780-19d75b9cf-ce12-f424-e053-dadaa90a57ceEarwax Treatment Drops

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1012-94ML - Milliliter0536-10121287a8f3-4982-4347-8b7a-84d43f1071a512015-03-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-643968788-6439-1
0536-1012

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Carbamide Peroxide31PZ2VAU81ACTIB
Water059QF0KO0RIACT
Anhydrous Citric AcidXF417D3PSLIACT
GlycerinPDC6A3C0OXIACT
Sodium Acid PyrophosphateH5WVD9LZUDIACT
Trisodium Citrate DihydrateB22547B95KIACT
Propylene Glycol6DC9Q167V3IACT
Trolamine9O3K93S3TKIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
107b5a32-577f-4153-a28e-8d62b9568e697006b786-ec05-44b1-b5b2-be07bc2219da2020-11-10WarningsExact identifier
spl set id: 7006b786-ec05-44b1-b5b2-be07bc2219da

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.