Rugby ® Earwax Treatment Drops

Manufacturer: Rebel Distributors Corp
Effective date: 2011-02-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:09

Label at a glance#

ProductEar Wax Treatment

Active ingredientCarbamide Peroxide

Label structure10 sections

Dosage and administration

FOR USE IN THE EAR ONLY adults and children over 12 years: 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 tilting head or placing cotton in ear use twice daily for up to 4 days remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe children under 12 years: ask a d...

Storage and handling

store at room temperature 15° - 30°C (59° - 89°F) keep in a dry place

Contacts and useful links#

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Use

INDICATIONS & USAGE SECTION

softens, loosens and removes excessive earwax

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use for more than 4 days

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

ear drainage or discharge
ear pain, irritation, rash or are dizzy
an injury or perforation (hole) of the eardrum or if you had ear surgery

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if earwax remains longer than 4 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY

adults and children over 12 years:

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 tilting head or placing cotton in ear
use twice daily for up to 4 days
remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe

children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature 15° - 30°C (59° - 89°F)
keep in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid (anhydrous), glycerin, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate (anhydrous), trolamine

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158
9am - 5pm ET
Monday - Friday

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 15 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX^®*

Rugby^®
NDC 21695-334-15

Earwax
Treatment
Drops

Carbamide Peroxide 6.5 %

Helps Remove
Excessive Earwax

1/2 fl oz (15 mL)

SATISFACTION GUARANTEED
Rugby
OR YOUR MONEY BACK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
702050	carbamide peroxide 6.5 % Otic Solution	PSN	1
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	1
702050	carbamide peroxide 6.5 % Otic Solution	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-334-15	2019-09-24	C162847	48780-1	934fe258-4aa6-48b1-e053-8cdaa90a720a	Rugby ® Earwax Treatment Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-334-15	Ear Wax Treatment	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-334	EAR WAX TREATMENT (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110211_22b7f3d7-7f3e-437f-9326-3eef737edfbb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-334-15	ML - Milliliter	21695-334	03ab23aa-e650-44b0-8f1d-947f5ec0bba3	1	2012-07-24
0536-3000-94	ML - Milliliter	0536-3000	863a7371-a8a9-4e1b-b4bd-6774b9883ec4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Carbamide Peroxide	ACTIVE INGREDIENT	31PZ2VAU81	1
Carbamide Peroxide	ACTIVE MOIETY	31PZ2VAU81	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Sodium Acid Pyrophosphate	INACTIVE INGREDIENT	H5WVD9LZUD	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Ear Wax Treatment
Carbamide Peroxide
Water
Citric Acid Monohydrate
Glycerin
Sodium Acid Pyrophosphate
Sodium Citrate
Propylene Glycol
Trolamine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21695-334	21695-334-15
0536-3000

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
Name	UNII	Kind
Carbamide Peroxide	31PZ2VAU81	ACTIB
Water	059QF0KO0R	IACT
Citric Acid Monohydrate	2968PHW8QP	IACT
Glycerin	PDC6A3C0OX	IACT
Sodium Acid Pyrophosphate	H5WVD9LZUD	IACT
Sodium Citrate	1Q73Q2JULR	IACT
Propylene Glycol	6DC9Q167V3	IACT
Trolamine	9O3K93S3TK	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 266 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		608 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SOAP / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
22b7f3d7-7f3e-437f-9326-3eef737edfbb			22b7f3d7-7f3e-437f-9326-3eef737edfbb	2011-02-09	Warnings	Exact identifier spl id: 22b7f3d7-7f3e-437f-9326-3eef737edfbb spl set id: 22b7f3d7-7f3e-437f-9326-3eef737edfbb

Reported adverse events (FAERS/openFDA)#

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