FDA.reportPublic FDA data

Earwax Treatment Drops

Manufacturer
Rugby Laboratories | Product Quest Mfg.
Effective date
2019-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:31:56

Label at a glance#

ProductEarwax Treatment Drops Rugby
Active ingredientCarbamide Peroxide
Label structure6 sections

Label contents#

Full prescribing information#

Active ingredient                        Purpose

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide  6.5%          Earwax removal aid

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen and remove excessive earwax

Purpose

OTC - PURPOSE SECTION

For occasional use as an aid to soften, loosen and remove excessive earwax

Warnings

WARNINGS SECTION


Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - STOP USE SECTION

Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

DirectionsFor 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 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.

INACTIVE INGREDIENT SECTION

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1124-94ML - Milliliter0536-1124c545295a-1fdb-4816-9521-e15b5086ebcc12017-08-11

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
0536-11240536-1124-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Carbamide Peroxide31PZ2VAU81ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Lauroyl Sarcosinate632GS99618IACT
Sodium StannateNJ7C1V83KGIACT
Water059QF0KO0RIACT

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
3d7929f7-c894-4301-bd5d-cc90d80e3f29b85dbfb0-8601-4603-af9f-397569cce6122019-01-15WarningsExact identifier
spl id: 3d7929f7-c894-4301-bd5d-cc90d80e3f29
spl set id: b85dbfb0-8601-4603-af9f-397569cce612

Reported adverse events (FAERS/openFDA)#

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